BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC

    MDR report key: 1060620 · Received June 13, 2008

    Report

    Report Number
    2023826-2008-00816
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 29, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS (OTHER) - A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THE LENS OPTIC IS TORN IN HALF AND A PORTION IS TORN OFF AND IS MISSING. ONE HAPTIC IS TORN. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD INSERTED A THREE PIECE SILICONE LENS MODEL AQ2003V AND REALIZED THE LENS WAS TORN. THE SURGEON ENLARGED THE INCISION TO REMOVE THE LENS AND ANOTHER SAME TYPE LENS WAS INSERTED, NO SUTURE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC INTRAOCULAR LENS HQL STAAR SURGICAL AQ2003V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT NUMBER 1235353| INJECTOR: MODEL MSI-PM, LOT NUMBER UNK| CARTRIDGE: MODEL AQCARTRIDGE-FP