BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE

    MDR report key: 731898 · Received June 23, 2006

    Report

    Report Number
    2023826-2006-00857
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    May 24, 2006
    Report Date
    May 25, 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
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: EVALUATION RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN INTO TWO PIECES AND ONE HAPTIC TORN. THE CARTRIDGE WAS RETURNED AND THERE WAS NO VISIBLE DAMAGE. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE AND REDDISH RESIDUE. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR WAS NOT RETURNED FOR EVALUATION. PMA# P9900048.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AQ2010V SILICONE THREE-PIECE LENS AND ONE HAPTIC TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES.

    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 68 YR INJECTOR MODEL MSI-TM - LOT NUMBER UNK.| CARTRIDGE MODEL AQ CARTRIDGE-FP - LOT # 1212843