BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER SINGLE PIEC

    MDR report key: 728212 · Received June 15, 2006

    Report

    Report Number
    2023826-2006-00771
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Report Date
    May 16, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSION BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETUURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION. PMA# IS P880091.

    Description of Event or Problem · 1

    THE SURGEON INSERTED AN AA4203TL TORIE SILICONE PLATE LENS AND THE LENS TORE. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY. NO INCISION ENLARGEMENT OR SUTURES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK