Bausch & Lomb ReNu with MoistureLoc Recall History

ReNu with MoistureLoc was removed from the market after the CDC discovered numberous cases of <"http://www.yourlawyer.com/topics/overview/fungal_keratitis">fusarium keratitis were linked to the product. The recall has slowed the outbreak of the fungal eye infection but it is estimated that MoistureLoc still holds over 2 percent of the market, because many people are still unaware that the solution has been recalled. Below is a detailed timeline of Bausch Lomb’s <"http://www.yourlawyer.com/topics/overview/renu_contact_solution">ReNu with MoistureLoc.

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)
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 DeviceBausch & 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.

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 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 DevicesAlcon 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.

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