BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU MULTIPLUS MULTI-PURPOSE SOLUTION

    MDR report key: 1516685 · Received October 23, 2009

    Report

    Report Number
    1313525-2009-00033
    Event Type
    Injury
    Date Received
    October 23, 2009
    Date of Event
    January 13, 2009
    Report Date
    September 28, 2009
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED. DOCTOR DOES NOT RELATE EVENT TO PRODUCT. DOCTOR STATED THIS TYPE OF INFECTION IS USUALLY CAUSED BY CONTAMINATED WATER. BASED ON ALL INFORMATION, NO CAUSAL FACTOR CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT REPORTED IRRITATION, REDNESS, AND BLURRY VISION IN BOTH EYES. AFTER BEING TREATED BY OPTOMETRIST WITH NO IMPROVEMENT, PATIENT VISITED OPHTHALMOLOGIST WHO DIAGNOSED BILATERIAL KERATITIS. THE RIGHT EYE WAS WORSE THAN THE LEFT EYE. THE OPHTHALMOLOGIST CONFIRMED THE CLINICAL APPEARANCE OF THE CORNEA WAS SUGGESTIVE OF ACANTHAMOEBA INFECTION. CULTURES WERE NEGATIVE. PATIENT FOLLOWED UP WITH ANOTHER DOCTOR WHO CONFIRMED CLINICAL DIAGNOSIS OF ACANTHAMOEBA INFECTION. PATIENT HAS SCARRING AND CORNEAL RING INFILTRATES AND IS CURRENTLY UNDER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU MULTIPLUS MULTI-PURPOSE SOLUTION LYL BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other| R ACQUITY CONTACT LENSES