BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1083159 · Received July 24, 2008

    Report

    Report Number
    2023826-2008-00994
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 3, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION OF RETURNED PROD FOUND NO VISIBLE DAMAGE TO THE LENS. THERE WAS EVIDENCE OF CLEAR SURGICAL DEVICE RESIDUE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVAL OF THE RETURNED PROD, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE RPTR STATED SOMETHING WENT WRONG DURING SURGERY AND THERE WAS PT CONTACT WITH AN AA4203TL TORIC SILICONE SINGLE PIECE LENS. ADD'L INFO HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO IS REC'D, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    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 CARTRIDGE MODEL AND LOT # UNK| INJECTOR MODEL AND LOT# UNK