BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU (UNKNOWN TYPE)

    MDR report key: 787866 · Received November 3, 2006

    Report

    Report Number
    1313525-2006-00536
    Event Type
    Injury
    Date Received
    November 3, 2006
    Date of Event
    March 10, 2002
    Report Date
    June 2, 2006
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS THAT RENU MULTIPLUS FORMULA IS EFFECTIVE, MEETS ALL PERFORMANCE CRITERIA AND NO CAUSAL FACTOR IS IDENTIFIED WITH THE REPORTED EVENT.

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM FDA'S MEDICAL PRODUCTS REPORTING PROGRAM THAT A PT REPORTED EXPERIENCING SEVERE EYE PAIN AND HER CORNEA "TURNED WHITE" WHILE USING RENU (UNKNOWN TYPE) 03/2002. THE PT SAW AN EYE SPECIALIST AND WAS DIAGNOSED WITH A CORNEAL ULCER. LATER THAT THE SAME YEAR, THE PT UNDERWENT A CORNEAL TRANSPLANT. ALTHOUGH REQUESTED, NO FURTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization