BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE

    MDR report key: 728145 · Received June 15, 2006

    Report

    Report Number
    2023826-2006-00819
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Date of Event
    May 15, 2006
    Report Date
    May 17, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT PART OF THE OPTIC AND A HAPTIC HAS BEEN TORN OFF AND WAS MISSING. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE. CONCLUSION BASED ON THE COMPLAINT HISTORY AND EVALUATION OF THE RETURNED PROUCT, 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 P900048

    Description of Event or Problem · 1

    THE SURGEON INSERTED AN AQ2010V SILICONE THREE PIECE LENS AND HAPTIC WAS TORN DURING INERTION. THE LENS WAS REMOVED WITHOUT ENLARGING THE INCISION NO SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR CARTRIDGE MODEL AQ CARTRIDGE-FP LOT NUMBER 1212205| INJECTOR MODEL MSI-TM, LOT NUMBER 1210622