BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU WITH MOISTURELOC

    MDR report key: 906008 · Received August 29, 2007

    Report

    Report Number
    MW5003593
    Event Type
    Injury
    Date Received
    August 29, 2007
    Date of Event
    February 26, 2007
    Report Date
    August 29, 2007
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER USING RENU WITH MOISTURELOC, I DEVELOPED AN ULCER ON MY LEFT CORNEA. I WAS TREATED AT EYE & EAR INSTITUTE, UPMC PRESBYTERIAN/SHADYSIDE FOR SIX MONTHS. TREATMENT INCLUDED STEROID EYEDROPS, ANTIBACTERIAL EYEDROPS AND ORAL ANTIBIOTICS. I HAVE A SCAR ON MY CORNEA AND PERMANENT VISION LOSS IN MY LEFT EYE. DATES OF USE: 10/15/2006 - 02/26/2007. DIAGNOSIS OR REASON FOR USE: RINSING, STORING AND CLEANING OF SOFT CONTACT LENS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU WITH MOISTURELOC NONE LPN BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R| S