BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU MULTIPLUS MULTI-PURPOSE SOLUTION

    MDR report key: 768224 · Received September 28, 2006

    Report

    Report Number
    1313525-2006-00460
    Event Type
    Injury
    Date Received
    September 28, 2006
    Date of Event
    April 25, 2005
    Report Date
    May 22, 2006
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT RETURNED PRODUCT IN BOTTLES WHICH WERE NOT THE ORIGINAL CONTAINERS. CHEMICAL TESTING OF THE PRODUCT RETURNED IN A BOTTLE, WHICH THE PT LABELED FROM LOT GJ3063B, FOUND THE PRODUCT MET SHELF-LIFE LIMITS FOR TESTS PERFORMED. CHEMICAL TESTING OF THE PRODUCT RETURNED IN A BOTTLE, WHICH THE PT LABELED FROM LOT GB5076A (EXPIRATION DATE 02/28/2007), FOUND THE PRODUCT MET SHELF-LIFE LIMITS FOR TESTS PERFORMED. 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. ALL OF THE RECORDS INDICATE THERE WERE NO ANOMALIES THAT COULD HAVE BEEN RELATED TO THE REPORT, THERE WERE NO FUSARIUM RECOVERIES FROM THE FACILITY ENVIRONMENTAL MONITORING PROGRAM OF THE ASEPTIC PROCESSING AREAS, AND ALL PRODUCT RELEASE STERILITY EVALUATIONS MET CRITERIA. PRODUCT RETAIN SAMPLE TESING WAS COMPLETED WHERE LOT NUMBERS WERE AVAILABLE AND INDICATED THAT ALL CHEMICAL AND BIOCIDAL PERFORMANCE WAS EFFECTIVE AGAINST MICROBIAL CHALLENGES AS REQUIRED. THE CONCLUSION OF THIS INVESTIGATION WAS THAT RENU MULTIPLUS FORMULA IS EFFECTIVE, MEETS ALL PERFORMANCE CRITERIA AND NO CAUSAL FACTOR IS IDENTIFIED WITH THE REPORTED EVENT. MFR DATE: 02/2005 (LOT GB5076A).

    Description of Event or Problem · 1

    A REPORT WAS REC'D VIA FDA'S MEDICAL PRODUCTS REPORTING PROGRAM THAT A MALE PT BEGAN TO EXPERIENCE DISCOMFORT IN HIS LEFT EYE IN LATE 04/2005. THE PT WAS USING RENU MULTIPLUS MULTI-PURPOSE SOLUTION AND A STORE BRAND GENERIC AT THAT TIME. AS HIS EYE PAIN INCREASED, THE PT PRESENTED TO AN EYE CLINIC WHERE HE WAS DIAGNOSED WITH A FILAMENTOUS FUNGUS [PSEUDALLESCHERIA BOYDII] CORNEAL ULCER. DUE TO RESIDUAL SCARRING, THE PT'S LEFT EYE HAS A VA OF 20/200. THE PT STATED THAT HE IS LEGALLY BLIND IN THE AFFECTED EYE AND MAY REQUIRE A CORNEAL TRANSPLANT. THE PT'S PHYSICIAN REPORTED THAT THE PT WAS DIAGNOSED WITH FUNGAL KERATITIS IN HIS LEFT EYE SECONDARY TO CONTACT LENS OVERWEAR AND REC'D UNSPECIFIED TREATMENT FOR 8 MONTHS. THE CORNEAL ULCER WAS LOCATED WITHIN THE CENTRAL 4 MM OF THE PT'S CORNEA; A CULTURE CONFIRMED A FILAMENTOUS FUNGI INFECTION. THIS CONDITION HAS RESULTED IN CORNEAL SCARRING AND A PERMANENT DECREASE IN VISION FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU MULTIPLUS MULTI-PURPOSE SOLUTION MULTI-PURPOSE SOLUTION FOR SOFT CONTACT LENSES LPN BAUSCH & LOMB, INC. NA GJ3063B

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R