BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION

    MDR report key: 731500 · Received June 29, 2006

    Report

    Report Number
    1313525-2006-00112
    Event Type
    Injury
    Date Received
    June 29, 2006
    Date of Event
    May 24, 2005
    Report Date
    April 12, 2006
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAUSCH & LOMB IS UNABLE TO COMPLETE AN INVESTIGATION OF THIS COMPLAINT SINCE NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE PHYSICIAN INDICATED THAT THIS EVENT WAS NOT DIRECTLY RELATED TO THE SOLUTION USED. THE PHYSICIAN ALSO NOTED THAT THE PATIENT SLEPT IN HER CONTACT LENSES OVER THE WEEKEND PRIOR TO HER SYMPTOMS BEGINNING BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSION CAN BE DRAWN. ALTHOUGH THIS COMPLAINT IS UNRELATED, BAUSCH & LOMB INITIATED AN INVESTIGATION THAT EVALUATED THE MANUFACTURING FACILITY ENVIRONMENTAL RECORDS, A REVIEW OF BATCH RECORDS AND TESTING OF RETAIN SAMPLES FOR NUMEROUS PRODUCED LOTS.THE CONCLUSION OF THIS INVESTIGATION IS THAT SOME ASPECT OF THE MOISTURELOC FORMULA MAY BE INCREASING THE RELATIVE RISK OF FUNGAL KERATITIS IN UNUSUAL CIRCUMSTANCES. WE ARE CONTINUING TO INVESTIGATE THIS LINK BUT IN THE MEANTIME, WE ARE TAKING THE MOST RESPONSIBLE ACTION IN THE INTEREST OF OUR CUSTOMERS BY DISCONTINUING THE MOISTURELOC FORMULA AND RECALLING ALL DISTRIBUTED PRODUCT.

    Description of Event or Problem · 1

    A 40-YEAR-OLD FEMALE PATIENT USING RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION WAS DIAGNOSED IN THE LEFT EYE WITH A MARGINAL CORNEAL ULCER (LIKELY STAPH), UVEITIS, BLURRY VISION, VISUAL DISCOMFORT, CORNEAL VASCULARIZATION, CONJUNCTIVAL HYPEREMIA, KERATITIS (OD) AND VITREOUS DEGENERATION (OU) ON 05/24/2005 AND 05/25/2005. SHE PRESENTED WITH A RED, IRRITATED LEFT EYE, INCREASED TEARS AND FOREIGN BODY SENSATION DUE TO A MASCARA USE. ZYMAR AND TOBREX QIH WAS PRESCRIBED. NO CULTURE DONE. ON 5/27/2005, CORNEAL ULCER WAS IMPROVING. TOBREX WAS DISCONTINUED AND BEGAN TOBRADEX. ON 06/02/2005, CORNEAL ULCER IMPROVED, AND CONJUNCTIVAL HYPEREMIA OS AND KERATITIS OD RESOLVED. ALLERGIC CONJUNCTIVITIS THEN NOTED. ELESTAT WAS PRESCRIBED. ZYMAR AND TOBRADEX DECREASED TO TID. ON 06/14/2005, CORNEAL ULCER RESOLVED. ZYMAR DISCONTINUED AND TOBRADEX TAPERED OFF AS DIRECTED. SHE DISCONTINUED CONTACT LENS WEAR AND HAD LASIK ON 06/24/2005. THE PHYSICIAN INDICATED THAT THIS EVENT WAS NOT DIRECTLY RELATED TO THE SOLUTION USED. THE PHYSICIAN ALSO NOTED THAT THE PATIENT SLEPT IN HER CONTACT LENSES OVER THE WEEKEND PRIOR TO HER SYMPTOMS BEGINNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION MULTI-PURPOSE SOLUTION FOR SOFT CONTACT LENSES LPN BAUSCH & LOMB, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention UNSPECIFIED CONTACT LENSES