BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-ABSORBING SILICONE PC IOL

    MDR report key: 41692 · Received September 5, 1996

    Report

    Report Number
    2020279-1996-00007
    Event Type
    Malfunction
    Date Received
    September 5, 1996
    Date of Event
    August 6, 1996
    Report Date
    September 3, 1996
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT OF THE MODEL 920 UV-ABSORBING SILICONE LENS THAT CRACKED DURING IMPLANT WAS REC'D FROM A CO SALES REP, OPHTHALMIC DIV. DURING IMPLANT, THE LENS STAYED FOLDED UPON RELEASE FROM THE FORCEP. THE CRACK WAS NOTED AT THE FOLD. AS THE PHYSICIAN BEGAN TO EXPLANT THE LENS, HE CUT THE LENS IN HALF AND DURING REMOVAL, THE HAPTIC BROKE. THE OTHER HALF OF THE LENS WAS REMOVED BY HOLDING THE HAPTIC WHILE PULLING IT OUT. SUBSEQUENTLY, THE HAPTIC JUNCTION TORE THE CAPSULAR BAG. A COMPETITOR LENS WAS IMPLANTED, WHICH ALSO CRACKED AND WAS REMOVED. ANOTHER ABSORBING SILICONE LENS WAS IMPLANTED SUCCESSFULLY. THE LENS WAS RETURNED TO THE MFR FOR EVAL. ADD'L INFO IS BEING SOUGHT FROM THE OPHTHALMOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-ABSORBING SILICONE PC IOL Implant INTRAOCULAR LENS HQL PHARMACIA IOVISION, INC. 920 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *