BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1040290 · Received May 8, 2008

    Report

    Report Number
    2023826-2008-00660
    Event Type
    Injury
    Date Received
    May 8, 2008
    Report Date
    April 21, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE LENS WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE RPTR STATED, THE SURGEON IMPLANTED AN AA4203TL TORIC SILICONE SINGLE PIECE LENS IN 2008. AT ONE DAY POST-OP, THE PT WAS NOT SATISFIED WITH THE OUTCOME. THE LENS WAS EXPLANTED TWO TO THREE WEEKS LATER AND ANOTHER DIFFERENT TYPE LENS WAS IMPLANTED. THE LENS WAS CUT IN HALF TO REMOVE WITH NO PT INJURY, NO ENLARGED INCISION OR SUTURES. THE LENS WAS DISCARDED BY THE FACILITY. THE RPTR STATED, THIS EVENT WAS PT RELATED AND WAS NOT LENS RELATED, THERE WAS NO PROBLEM OR MALFUNCTION OF THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CARTRIDGE MODEL MTC-60C FP - LOT # UNK| INJECTOR MODEL AND LOT# UNK