BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH MPDS

    MDR report key: 883706 · Received July 23, 2007

    Report

    Report Number
    1610287-2007-00025
    Event Type
    Injury
    Date Received
    July 23, 2007
    Date of Event
    June 22, 2007
    Report Date
    June 22, 2007
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. EVALUATION OF RETENTION SAMPLE FROM LOT 124080F IS IN PROGRESS. BATCH RECORD REVIEW IS IN PROGRESS. NO SIMILAR REPORTS ON LOT 124080F. UNLABELED. CODES PROVIDED BY MANUFACTURER. THIS REPORT MAILED IN TO FDA ON: 07/20/2007. ADD'L INFO WAS REQUESTED FROM CONSUMER: 06/26/2007, 07/13/2007, 07/16/2007 (2), AND 07/17/2007. NO ADD'L INFO WAS PROVIDED BY CONSUMER.

    Description of Event or Problem · 1

    CONSUMER REPORTS EXPERIENCING EYE PAIN AND SEEING SPOTS AFTER USING THIS PRODUCT FOR THE FIRST TIME. SHE STATES SHE WAS EXAMINED BY A PHYSICIAN WHO DIAGNOSED "CHEMICAL BURNS" BILATERALLY, AND TREATED HER WITH EYE DROPS (NOT SPECIFIED). SHE INDICATES THE PHYSICIAN DISCARDED HER LENSES (BRAND NOT SPECIFIED) AND TOLD HER TO NOT GO TO WORK THAT DAY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH MPDS LENS CARE DISINFECTING SOLUTIONS LPN ALCON LABORATORIES, INC. NA 124080F

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other