What Bausch & Lomb Knew About Renu With Moistureloc® And When They Knew It

ReNu with MoistureLoc® Timeline

May 5, 2003 – Bausch & Lomb filed a Summary 510(k) (K031646) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC03”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution”. Under “Predicate Devices”, Bausch & Lomb describe the solution:

Description of the Device
Bausch & Lomb Multi-Purpose Solution NRC03 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with polyaminopropyl biguanide (0.0001 %). (emphasis added)

Note: This is a Multi-Purpose Solution that is essential the same as ReNu with MoistureLoc, accept it uses PHMB as a disinfectant.

December 11, 2003 – Bausch & Lomb filed a Summary 510(k) (K033854) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC07”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution” and “Bausch & Lomb Multi-Purpose Solution NRC03”. Under “Predicate Devices”, Bausch & Lomb describe the solution:

Description of the Device
Bausch & Lomb Multi-Purpose Solution NRC07 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with Alexidine dihydrochloride (0.00045%). (emphasis added)

NOTE: 2 observations regarding the May 5 and December 11, 2003 entries. They are the identical product except for the preservative used. Except that the preservative used in the May 5th filing was PHMB, and the preservative used in the December 11th filing was alexidine. Both 510(k)’s were filed using the incorrect “Proprietary Name” which should have been the name of the product intended to be used in marketing.

December 14, 2003 – The Food and Drug Administration (FDA) approved Bausch & Lomb’s 510(k) (K031646) for “Bausch & Lomb Multi-Purpose Solution NRC03”.

May 19, 2004 – The Food and Drug Administration (FDA) approved Bausch & Lomb’s 510(k) (K033854) for “Bausch & Lomb Multi-Purpose Solution NRC07”.

Note: This is ReNu with MoistureLoc.

4th Quarter, 2004 – Bausch & Lomb, with much fanfare, launched ReNu with MoistureLoc.

June 29, 2005 – Bausch & Lomb filed a Summary 510(k) (K051755) for a product they called “Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution” and “Bausch & Lomb Multi-Purpose Solution NRC03”. Under “Predicate Devices” and “Description of Device” Bausch & Lomb describes the solution:

Predicate Devices
Alcon OPTI-FREE Express Multi-Purpose Disinfecting Solution and Ciba Vision AQuify Multi-Purpose Solution have been selected as the predicate devices for Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution.

Description of Device
Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with alexidine dihydrochloride (0.00045%). (emphasis added)

NOTE: The only difference in this 510(k) and in the 510(k) for “Bausch & Lomb Multi-Purpose Solution NRC07” is a new indicated use was added for “silicone hydrogel lenses”.

NOTE: This 510(k) did not reference as a “Predicate Device” either of the 2 previously filed and approved devices for “Bausch & Lomb Multi-Purpose Solution NRC03” or “Bausch & Lomb Multi-Purpose Solution NRC07”. Interestingly, NRC07 is ReNu with MoistureLoc.

NOTE: About this time, reports from Asia are coming out regarding an increase in Fusarium keratitis. See: July, 2005. Is it reasonable to think Bausch & Lomb had spontaneous reports prior to the July, 2005 meeting?

July, 2005 – Ophthalmologists at the Hong Kong Hospital Authority, while holding a periodic review, voiced concern about “an unusually high yield of Fusarium from patients’ clinical specimens sent for culture” (per the authority pronouncement on May 20, 2006).

August, 2005 – Hong Kong Health Department put out a public alert about a recent outbreak of 4 cases of keratitis. They warned the public to clean contact lenses carefully. No connection to Bausch & Lomb ReNu products is mentioned.

October 20, 2005 - Hong Kong health officials formally placed Bausch & Lomb on notice of a potential link between the outbreak of keratitis and ReNu with MoistureLoc. Apparently Bausch & Lomb didn’t inform the Food and Drug Administration (FDA) of this notification, the Singapore Ministry of Health (MOH) or Malaysia health department of the Hong Kong action.

November 11, 2005 – After no response by Bausch & Lomb to the October 20, 2005 notice, Hong Kong health officials again formally placed Bausch & Lomb on notice of a potential link between the outbreak of keratitis and ReNu with MoistureLoc. Apparently Bausch & Lomb didn’t inform the Food and Drug Administration (FDA) of this notification, the Singapore Ministry of Health (MOH) or Malaysia health department of the Hong Kong action.

November 17, 2005 – The Food and Drug Administration (FDA) approves the 510(K) filing by Bausch & Lomb for ReNu with MoistureLoc, issuing a “substantially similar” letter to Bausch & Lomb regarding their Summary 510(K) application.

December, 2005 – Malaysia health department started an investigation into the spike of fugal corneal infections recently observed in Malaysia.

December, 2005 – Bausch & Lomb files a document with the Food and Drug Administration (FDA) indicating that there was a outbreak of 15 cases of Fusarium keratitis in Hong Kong, but did not mention any relationship with any Bausch & Lomb product or that the Hong Kong Health Department formally placed Bausch & Lomb on notice of a potential link between the outbreak of keratitis and ReNu with MoistureLoc.

January 27, 2006 - In a letter to the Singapore Ministry of Health from Donald Tan, the deputy director of Singapore’s National Eye Center disclosed that the center had seen a surge of 13 Fusarium cases. All the patients were contact lens users and had one other thing in common: they used a Bausch & Lomb’s contact lens solution.

February 7, 2006 – Bausch & Lomb wrote to Hong Kong health officials claiming that there was no connection between the Fusarium keratitis and any Bausch & Lomb product and therefore, no remedial measures by Bausch & Lomb were necessary.

February 17, 2006 – Bausch & Lomb received a report from Singapore Ministry of Health (MOH) that strongly associated a sudden spike of 7 cases of fungal corneal infections noticed by Singapore National Eye Centre (SNEC) in January, 2006 with the use of ReNu with MoistureLoc. As a result of this finding, Singapore officials undertook a retrospective review of cases in SNEC, which revealed a total of 19 patients had been treated at SNEC for culture positive fungal corneal infections due to the Fusarium fungus species since May 2005 (i.e. about one to two cases per month). The Ministry was further notified this week of 3 new cases in Changi General Hospital. The Singapore Ministry of Health (MOH) noted that some of the patients have suffered significant loss of vision in the affected eye as a result of the fungal corneal infection and that three patients had to undergo urgent corneal transplantation. The Singapore Ministry of Health (MOH) called the incidences of fungal corneal infections “unprecedented”. Singapore Ministry of Health (MOH) noted that “all the patients used disposable soft contact lenses, which were cleaned and stored with multi-purpose contact lens solution. 18 of the 19 patients seen by SNEC as well as the 3 patients from CGH reported that they had used Bausch and Lomb’s ReNu multipurpose contact lens solution.” Health Sciences Authority (HSA) has notified Bausch and Lomb of the association with ReNu multipurpose contact lens solution.

With all that, Bausch & Lomb did not notify the Food and Drug Administration (FDA) of this notification. Nor did Bausch & Lomb did not warn its customer to stop use existing supplies

February 17, 2006 – Bausch & Lomb started its own investigation of the Greenville, South Carolina plant, the same day Singapore reported its belief that the Fusarium keratitis outbreak was due to ReNu with MoistureLoc

February 17, 2006 - The Singapore Ministry of Health (MOH) alerted the public to a possible link between the Bausch & Lomb’s ReNu “multipurpose contact lens solution” and fungal corneal infections. They did not specifically mention ReNu with MoistureLoc. They reminded users that proper contact lens practices included the thorough rubbing and rising of contact lenses before soaking overnight in a multi-purpose solution, not to use contact lenses beyond their disposal period, daily changing of multi-purpose solution from the lens case in all circumstances, replace the contact lens case every 3 months.

February 17, 2006 - Bausch & Lomb says it suspended sales that day of ReNu with MoistureLoc in Singapore and Hong Kong. Notably, Bausch & Lomb did not instruct users of any ReNu contact lens solutions not to use the existing product or to throw out any remaining solution until late April, 2006. Again, the Food and Drug Administration (FDA) was not notified of this action at this time

February 20, 2006 - Singapore Ministry of Health (MOH) issued a new, stronger warning and recommended that contact lens wearers, “as a precautionary measure”, to stop using Bausch & Lomb’s ReNu “multipurpose contact lens solution”. They did not specifically mention ReNu with MoistureLoc. The MOH reiterated the warnings as to the proper uses of contact lenses and multi-purpose contact lens solutions. Again, the Food and Drug Administration (FDA) was not notified of this action at this time.

Singapore researchers have now found 39 cases of Fusarium infection among contact lens wearers, 34 of whom recall using the ReNu solutions. Four could not remember which solution they used. Most telling, the MOH said the infections began to increase in November 2004, the month that Bausch & Lomb began selling the solution in Singapore.

February 21, 2006 - Singapore Ministry of Health (MOH) issued another press release with more detailed information of their current findings. The MOH “strongly” advised all contact lens users to discontinue the use of Bausch & Lomb’s ReNu “multipurpose contact lens solution”. They did not specifically mention ReNu with MoistureLoc. The MOH reiterated the warnings as to the proper uses of contact lenses and multi-purpose contact lens solutions.

February 23, 2006 – The Star, a Malaysian newspaper, reported that the Malaysian Health Ministry advised that contact lens wearers should stop using Bausch & Lomb’s ReNu lens solution because of a “very strong association” between it and a recent spate of fungal corneal infections. Again, the Food and Drug Administration (FDA) was not notified of this action at this time.

February 25, 2006 - The Star, a Malaysian newspaper, quoted Bausch & Lomb’s South-East Asia’s managing director Foo Eng Chuan was quoted as saying that his company would not suspend the sales of ReNu multi-purpose solution in Malaysia. The reason: “There had been no report of corneal infection in Malaysia so far.” Mr. Chuan made that statement confirming that Bausch & Lomb would not suspend sales of any of the ReNu multi-purpose lens care solutions in Malaysia since, “There had been no report of corneal infection in Malaysia so far.”

March 3, 2006 – Dr. David S. Chu, a New Jersey ophthalmologist and a specialist in cornea diseases, called Dr. Brian Levy, Bausch & Lomb’s Vice President and Chief Medical Officer (holds a degree in optometry), to alert him of 3 of his patients who developed fungal infections while using a Bausch & Lomb ReNu product.

March 8, 2006 - Dr. David S. Chu notifies the Center for Disease Control and Prevention (CDC) of his patients experience with Bausch & Lomb ReNu products. Despite what Dr. Levy told the Rochester Democrat Chronicle in their April 21, 2006 story, it seems Dr. Chu was 1st to notify the CDC and not Bausch & Lomb.

March 15 2006 – Malaysian health officials ordered the immediate removal of all of Bausch & Lomb’s ReNu brand multi-purpose contact lens solutions from the shelves.

March 22, 2006 - Food and Drug Administration (FDA) began an unusually intensive investigation of Bausch & Lomb’s, Greenville, South Carolina plant where the Bausch & Lomb Renu contact lens solutions distributed to the U.S., Singapore, Malaysia, Hong Kong and most of Asia are manufactured by dispatching a team of 5 investigators to the plant. The Food and Drug Administration (FDA) inspection of Bausch & Lomb’s Greenville, South Carolina site was conducted from March 22, 2006 to May 15, 2006.

March 31, 2006 - Bausch & Lomb issued its 1st press release in the U.S. on the fungal infection issue, indicating that it is collaborating in a surveillance program and scientific investigation to track and investigate the incidence of the infection with health authorities and leading experts around the world including the United States. However, Bausch & Lomb stated that it did not believe any of its contact lens care products were involved.

April 10, 2006 – The Center for Disease Control and Prevention (CDC) released its 1st data regarding Fusarium keratitis in its Morbidity & Mortality Weekly Report (MMWR). In the release, the CDC stated that it received reports of 109 cases of suspected fungal keratitis in 17 different states. While they noted that the majority of case patients have yet to be interviewed, complete data are available for 30 of them; 28 of the 30 wore soft contact lenses. From the information obtained by CDC from patient interviews, 26 of these patients remembered which products they used, and all 26 reported using a Bausch & Lomb ReNu brand contact lens solution in the month prior to the onset of infection.

April 10, 2006 - Food and Drug Administration (FDA) issued a press release which essentially summarized the release by The Center for Disease Control and Prevention (CDC).

April 10, 2006 - Bausch & Lomb suspended U.S. shipments of ReNu with MoistureLoc to retailers and distributors “as a precaution” but did not withdraw the existing product from the shelves.

April 10, 2006 – Bausch & Lomb issues a press release commenting on the data released by The Center for Disease Control and Prevention (CDC). Bausch & Lomb stated in part:

Today’s announcement follows the release of a report by the U.S. Centers for Disease Control and Prevention (CDC) that it is reviewing reports of 109 cases of suspected fungal keratitis. The CDC reports that the majority of cases have yet to be reviewed, but of the 30 cases reviewed to date, 28 involved contact lens wearers. Twenty-one reported using ReNu brand contact lens care products and 5 reported using a combination of ReNu and products manufactured by other companies.

“Bausch & Lomb’s first priority is the health and safety of consumers,” said Ronald L. Zarrella, chairman and CEO of the company. "The CDC data released today are both troubling and perplexing, as there is an apparent disproportionate representation of U.S. manufactured ReNu with MoistureLoc in the underlying data. The source of these infections has not been determined. Based on our extensive testing, analysis and further internal reviews, and communications with leading experts, the available scientific evidence does not establish any type of ReNu solution as a cause.

April 10, 2006 – At about this time, Bausch & Lomb, in anticipation of the impending need, starts to ramp up production of their contact lens solutions which do not contain MoistureLoc.

April 11-12, 2006 – Several major U.S. retailers removed ReNu brand multi-purpose contact lens solutions products from their shelves. Walgreen Co., the largest U.S. drugstore chain, told its stores Wednesday to pull all ReNu products from its shelves, not just the MoistureLoc product. Wal-Mart Stores Inc., the world’s largest retailer, stopped selling ReNu with MoistureLoc “pending further test results from the U.S. Centers for Disease Control and Prevention,” the company said in a statement. Wal-Mart said it would still sell other Bausch & Lomb ReNu products unaffected by the CDC investigation. Rite Aid Corp., the No. 3 U.S. drugstore chain, also removed MoistureLoc products but continuing to sell other products in the ReNu line.

April 12, 2006 - Singapore Ministry of Health (MOH) issued another press release indicating that an additional 36 cases of fungal infection was reported since the last update in late February (then 39 cases). In total, 75 cases of fungal corneal infection with a history of contact lens use have been reported for the period from November, 2004 to April 12, 2006. The MOH reiterated its previous advisory to discontinue the use of Bausch & Lomb’s ReNu “multipurpose contact lens solution”. They did not specifically mention ReNu with MoistureLoc. The MOH also restated the warnings as to the proper uses of contact lenses and multi-purpose contact lens solutions.

April 13, 2006 - Bausch & Lomb withdraws ReNu with MoistureLoc from the store shelves in the U.S. By then many retailers including Wal-Mart, Walgreens and CVS had already started to pull the product from their shelves. Bausch & Lomb did not ask retail stores to return the unsold product to Bausch & Lomb.

April 14, 2006 – The Center for Disease Control and Prevention (CDC) released its 1st data regarding Fusarium keratitis as a press release. It is essentially the same information it released in its Morbidity & Mortality Weekly Report (MMWR) on April 10, 2006.

April 14, 2006 – This was the first day of a two-day national Bausch & Lomb ad campaign.

April 17, 2006 – The first personal injury and class-action lawsuit representing ReNu users with eye infections filed against Bausch & Lomb in federal district court. Parker & Waichman, LLP filed the Kimberly A. Beskin vs. Bausch & Lomb Incorporated case in the Federal District Court, Eastern District of New York. The lawsuit seeks inter alia recovery for the named plaintiff, recovery for all those similarly situated and for the cost of medical and related expenses for the medical monitoring of those patients who have used Bausch & Lomb ReNu with MoistureLoc

April 27, 2006 - The Center for Disease Control and Prevention (CDC) published a web page entitled “General Information about Fusarium Keratitis”
May 2006 – By the beginning of May, Bausch & Lomb determined that the source of the fungus was most likely not the result of contamination of the contact lens solution since several distinctively different strains of fungi was found to have infected users. Also Bausch & Lomb claimed the tests showed that the contact lens solutions actually killed the fungus.

May 2, 2006 –
• The CDC issued updated data.
• The CDC now received 191 reports of eye infections caused by Fusarium keratitis, including 86 confirmed cases.
• This was up from 186 reports and 73 confirmed cases the prior week.
• Fifty-eight of the cases involved contact lens users.
• 54 of them saying they had used lens cleaning solutions from Bausch & Lomb.

May 3, 2006 - Bausch & Lomb issues a press release concentrating on defending the ReNu MultiPlus line, stating in part:

In the small sample of cases CDC has analyzed to date, the 27-percent representation of ReNu® MultiPlus® solution is well below its approximate 40-percent market share. MultiPlus solution is used by nearly 11 million contact lens wearers in the U.S. in either its branded or private label form. More than 30 million consumers worldwide have used MultiPlus, which has maintained an excellent record of safety and effectiveness since it was introduced in 1997.

• Bausch & Lomb for the first time confirmed its ReNu contact solution has been linked to a “handful” of eye infection cases in Europe.
• ReNu contact lens solutions for the European market are manufactured at a plant in Milan, Italy which also supplies Middle Eastern and African markets.
• No reports on infections have come from ReNu products manufactured at the Beijing, China or and Bhiwadi, India plants.

May 5, 2006 -
• The CDC issues a further update.
• The CDC has received reports of 102 confirmed cases, 12 possible cases and 81 cases still under investigation
• 65 reports include insufficient evidence to classify them as cases
• As of May 2, 2006, of the 58 confirmed cases for which CDC has complete data:

• 56 wear contact lenses
• 32 reported using any B&L ReNu with MoistureLoc
• 15 reported using any B&L ReNu MultiPlus
• 7 reported using any unspecified B&L ReNu
• 3 reported using any AMO product
• 3 reported using any Alcon product

* Some cases reported using more than one type of solution and therefore the solution categories are not mutually exclusive.

May 11, 2006 -
• Bausch & Lomb met with FDA officials to share information resulting from the company’s internal investigation into cases of Fusarium keratitis associated with ReNu with MoistureLoc.
• The company proposed that unique characteristics of the formulation of ReNu with MoistureLoc in certain cases can increase the risk of Fusarium infection.

May 12, 2006 -
• The CDC reported 122 confirmed cases of fungal eye infections.
• Investigation was completed in 98 cases with confirmed fungal eye infection.
• 93 involved contact lens wearers.
• 86 of the contact lens wearers (93%) reported using Bausch & Lomb ReNu contact lens solutions.
• 59 (63%) of the infected contact lens wearers used ReNu with MoistureLoc.
• Bausch & Lomb says ReNu with MoistureLoc accounts for only 10% of total contact lens solution sales in the U.S.
• In 19 (20%) of the infected contact lens wearers, they used ReNu MultiPlus.
• Bausch & Lomb says ReNu MultiPlus accounts for 40% of the total contact lens solution market in the United States.
• In 9 (10%) cases which reported using a ReNu brand, the user could not specify which one.
• In 4 (4%) cases, Alcon contact lens solutions were reportedly used.
• In 3 (3%) cases, Advanced Medical Optics (AMO) contact lens solutions were reportedly used.

May 15, 2006 -
• Bausch & Lomb announced a worldwide recall of ReNu with MoistureLoc.
• Bausch & Lomb concluded the product’s formula may increase the risk of fungal eye infections in certain situations.
• Bausch & Lomb and the FDA said the problem lies in the unique chemical properties of ReNu with MoistureLoc.
• Testing revealed that ReNu with MoistureLoc allows a polymer film to form around the Fusarium fungus preventing alexidine, the disinfectant in ReNu with MoistureLoc, from killing the fungus.
• Bausch & Lomb stated that the problem was related to the design of this particular solution and does not involve the other multi-purpose Bausch & Lomb contact lens solutions.

Bausch & Lomb, in a telephone interview stated the following:

B&L Chief Executive Ronald Zarrella and Praveen Tyle, chief scientific officer, said there was enough evidence to show that an eye comfort-enhancing polymer unique to the MoistureLoc formula could be an inadvertent culprit.

The polymer, they said, can prevent the solution from disinfecting properly in cases of poor hygiene.

For example, contact lens users who “top off” their lens solutions rather than emptying used solution and thoroughly cleaning lens cases run the risk of allowing the buildup of a polymer film that could block the disinfecting chemicals from working properly. Praveen Tyle, Bausch’s chief scientific officer, said the film might form under “extreme circumstances” -- for instance, if the lens case is left open and some solution evaporates.

“What we believe is happening is in cases where the liquid is allowed to evaporate in the lens case or dumped out and allowed to dry without being completely cleaned, or if a (bottle) flip cap is left open, these polymers form a film on the surface,” Zarrella said. In wearers who are infection-susceptible because of corneal damage or certain eye drugs they are using, “a perfect storm” scenario may arise that will lead to the fungal infection, Chief Executive Ronald Zarrella said.

“If the polymer comes into contact with Fusarium in the environment, the Fusarium can adhere to that surface and basically hide from the ability of (the disinfectant) to come through and kill it.”

The FDA issued a press release that stated “based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium, Bausch & Lomb has decided to permanently remove the ReNu with MoistureLoc product worldwide.”

May 16, 2006 - The FDA released the findings of their investigation of Bausch & Lomb’s South Carolina plant dated May 15, 2006. Notably, in “Observation #4”, the FDA found:

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.

Specifically,

a. The firm failed to notify the agency of 35 serious injury reports of Fusarium Keratitis from Singapore’s Minister of Health in February 2006 relating to ReNu MoistureLoc Multi-Purpose Solution. None of the complaints were reported to the Agency as of April 7, 2006.

b. Complaint #S105000240 - #S105000245 were initially reported to the firm as Keratitis complaints in July 2005. These complaints have not been reported to the Agency as of May 9, 2006.

The FDA stated their investigation disclosed a total of 20 violations of FDA regulations.


May 17, 2006 - Bausch & Lomb officials disputed the May 16th FDA findings:

• That BOL failed to timely report problems related to the contact lens solution as early as July 2005.
• That BOL failed to immediately report information about 35 fungal keratitis eye infection cases provided in February 2006 from the MOH.

May 19, 2006 - The CDC released their latest MMWR. In it, they summarized the data to date as follows:

As of May 18, 2006:

• 130 confirmed cases of Fusarium keratitis infection with symptom onset after June 1, 2005.
• 125 reported wearing contact lenses.
• 118 were able to identify which contact lens solution(s) they had used during the month before onset.
• 75 (64%) reported using Bausch & Lomb’s ReNu with MoistureLoc alone.
• 14 (12%) reported using MoistureLoc in combination with another product.
• 8 (7%) reported using an unspecified Bausch & Lomb solution.
• 21 (18%) reported using only products other than MoistureLoc, from various manufacturers.
• Ongoing surveillance continues to identify persons who used MoistureLoc and had disease onset.
• None had a history of recent ocular trauma.
• Corneal transplantation was required in 37 of 120 (31%) cases.

The results of this case-control investigation indicate an increased risk for Fusarium keratitis associated with use of Bausch & Lomb’s ReNu with MoistureLoc. The cause of this association is not clear; however, further studies, including environmental and molecular testing, are ongoing. Although certain patients have reported use of other contact lens solutions, the analysis does not indicate that these products are associated with significantly increased risk for disease. Patients who reported using only products other than MoistureLoc might not have recalled all the contact lens solutions they had used, especially if the period between exposure and interview was lengthy.

May 19, 2006 - Bausch & Lomb continued to defend ReNu products in a press release in response to the CDC’s MMWR (May 19th) which stated in part:

• The CDC’s findings affirm the company’s decision to recall its MoistureLoc solution.
• Consumers should have continued confidence in ReNu MultiPlus® and ReNu MultiPurpose lens care products, sighting that the “MoistureLoc formulation was the only product with a statistically significant association with reports of Fusarium keratitis.”

August 23, 2006 – The multistate investigation designed by the CDC and conducted by in cooperation of various state and local health departments was published in the Journal of the American Medical Association (JAMA). The study made several significant findings:

• The 1st report of Fusarium keratitis in the United States was made by Dr. David S. Chu, a New Jersey ophthalmologist and a specialist in cornea diseases on March 8, 2006 (as noted above) and not as Dr. Levy told the Rochester Democrat Chronicle in their April 21, 2006 story claiming that Bausch & Lomb was the 1st to notify the CDC of Dr. Chu’s report to them.
• The outbreak of Fusarium keratitis was associated with the use of ReNu with MoistureLoc
• The Fusarium keratitis was likely caused as a result of extrinsic contamination of the contact lens solution bottle or contact lens cases outside the manufacturing or storage process
• Suboptimal hygiene practice appeared unlikely to contribute to the outbreak
• The unique properties of ReNu with MoistureLoc formula may have contributed to the outbreak of fungal infections
• Biofilm on the contact lenses or contact lens cases may have played a role in the outbreak
• Some hygiene practices may have facilitated the growth of biofilms
• Fusarium may have specific qualities promoting adherence and penetration into the contact lenses that allow survival within contact lens cases whyen used with ReNu with MoistureLoc

The study was limited by the following criteria:

• The patient could not have had any history of eye trauma for 30 days prior to the diagnosis
• There had to have been a positive culture from a corneal scraping (not from the contact lens bottle or the contact lens case)
• The diagnosis had to have been made after June 1, 2005
• The case had to be identified before April 10, 2006
• Patients had to have been 18 years of age or older
•
August 23, 2006 – In an accompanying Commentary that was published in the same edition of the Journal of the American Medical Association (JAMA), the two authors, both medical doctors, one also a PhD and one a MPH noted:

• Ophthalmologists in developing countries have been warning for years that corneal blindness as a result of bacterial and fungal ulcers is a “silent epidemic”.
• Discussions and debates at professional meetings and on professional list servers suggest that this epidemic may be even larger than recognized by the CDC
• There is a broader question – that is whether multipurpose contact lens solutions are less effective against fungi than lens care systems that use a separate disinfectant solution such as hydrogen peroxide
• One-fourth of the cases received topical corticosteroid prior to referral and initiation of antifungal therapy
• Appropriate antimicrobial therapy for fungal keratitis has yet to be determined.

Contact Information

Jason Mark

Esq.

Parker & Waichman, LLP

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