BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1063491 · Received June 20, 2008

    Report

    Report Number
    1610287-2008-00018
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. EVALUATION OF A RETENTION SAMPLE FROM LOT 135939F IS IN PROGRESS. BATCH RECORDS WERE REVIEWED AND NO DEVIATIONS WERE IDENTIFIED. NO SIMILAR REPORTS FOR LOT 135939F. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CONSUMER . CONSUMER PROVIDED INFORMATION. INFORMATION WAS REQUESTED FROM THE ATTENDING PHYSICIAN. NO INFORMATION WAS RECEIVED FROM THE PHYSICIAN.

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING OCULAR "BURNING, REDNESS, PAIN", AND SHE "COULDN'T SEE", LEFT EYE (OS), AFTER INSERTING A CONTACT LENS INTO THE LEFT EYE AFTER USING THIS PRODUCT. SHE STATED SHE HAD INADVERTENTLY SLEPT IN HER LENSES OVERNIGHT AND REMOVED THEM THAT MORNING FOR CLEANING. THE CONSUMER VISITED A PHARMACIST WHO GAVE HER A SALINE SOLUTION TO RINSE THE EYE (OS), BUT THIS PROVIDED NO RELIEF. LATER IN THE DAY, SHE HAD "SEVERE PAIN" AND VISITED A HOSPITAL EMERGENCY ROOM WHERE THE ATTENDING PHYSICIAN SAID IT LOOKED LIKE A "CHEMICAL BURN" AND ALSO OBSERVED THERE WERE TWO SCRATCHES. SHE INDICATED THE PHYSICIAN TREATED HER WITH AN ANALGESIC FOR PAIN AND ANTIBIOTIC EYE DROPS TO PREVENT INFECTION. THE CONSUMER COMPLAINED ALSO OF HAVING A "SEVERE HEADACHE" AND "FEELING NAUSEATED" WHILE IN THE EMERGENCY ROOM. IN 2008, THE CONSUMER REPORTED HER VISION WAS CLEAR AND THE SYMPTOMS RESOLVED EXCEPT FOR A SLIGHT HEADACHE ON THE LEFT SIDE OF HER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA 135939F

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention