BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 2903718 · Received December 31, 2012

    Report

    Report Number
    MW5028443
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    June 2, 2004
    Report Date
    December 31, 2012
    Manufacturer
    UNKNOWN
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER HAVING LASIK SURGERY ON BOTH EYES, I DEVELOPED PREMATURE CATARACTS AND WAS NOT ADVISED THAT THIS COULD OCCUR AND THAT IN HAVING THE LASIK SURGERY THAT I WOULD BE ADVERSELY LIMITED IN FUTURE EYE PROCEDURES INCLUDING CATARACT SURGERY. AFTER A RETINAL DETACHMENT, I AM NOW FACING CATARACT SURGERY AND AM NOT A CANDIDATE FOR SOME LENSES DUE TO MY LASIK SURGERY AND WAS FURTHER INFORMED THAT THE PRIOR SURGERY COULD ADVERSELY AFFECT THIS SURGERY. I BELIEVE THAT THESE WARNINGS AS WELL AS THE PREOPERATIVE MEASURING OF THE EYE SHOULD BE MANDATORY. LASIK SURGERY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASIK LASIK LZS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| S LASIK SURGERY