BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFREE

    MDR report key: 53346 · Received December 4, 1996

    Report

    Report Number
    MW4001822
    Event Type
    Injury
    Date Received
    December 4, 1996
    Date of Event
    September 12, 1996
    Report Date
    November 8, 1996
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER A FEW HRS OF CONTACT LENS WEAR, PT'S EYES BEGAN TO BURN WITH REDNESS AND TEARING. SHE HAD USED THE DISINFECTANT PRODUCT TO DISINFECT THE LENS. PT'S CORNEAL EPITHELIUM SLOUGHED O.U. OVER THE NEXT FEW DAYS AND RE-EPITHELIDIZATION DID NOT OCCUR UNTIL 3 WEEKS LATER OD, 4 WEEKS OS. THE PT WAS IN EXCRUCIATING PAIN FOR MUCH OF THAT TIME AND WAS OUF OF WORK UNTIL MID-OCT. PT REQUIRED STRONG PAIN MEDS AND SLEEPING PILLS. DX: SEVERE CHEMICAL KERATOCONJUNCTIVITIS WITH PROBABLE STEM CELL DAMAGE OF CORNEA OS & OD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFREE LENS SOLUTION CLEANER LPN ALCON LABORATORIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R| S