BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPHTEC

    MDR report key: 1415189 · Received July 15, 2009

    Report

    Report Number
    MW5012002
    Event Type
    Injury
    Date Received
    July 15, 2009
    Date of Event
    November 29, 2006
    Report Date
    July 9, 2009
    Manufacturer
    OPHTEC USA, INC.
    Product Code
    HQL
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS NEVER AROUND AFTER THE SURGERY. THE ONLY THING HIS GROUP HAD TO OFFER ME WAS, "OH, WE STAY IN CLOSE CONTACT WITH HIM." THIS IS "VISION GROUP", BY THE TIME I FIRED HIM AND WENT TO ANOTHER PHYSICIAN, IT WAS TOO LATE TO SAVE MY SIGHT IN THE LEFT EYE; RETINA WAS BASICALLY GONE. IN CONTACTING THE PRODUCT MANUFACTURER BY PHONE, THEY WERE SHORT WITH ME AND SAID, IF I HAD ANY QUESTIONS ABOUT THE PRODUCT THAT I WOULD HAVE TO GET IN TOUCH WITH THE PHYSICIAN. THIS TYPE OF LENS SHOULDN'T BE USED, ESPECIALLY ON AN ANIRIDIA PATIENT, BECAUSE IT IS TOO LARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTEC INTRAOCULAR IMPLANT HQL OPHTEC USA, INC. 311

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability