BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1366224 · Received March 19, 2009

    Report

    Report Number
    2023826-2009-00284
    Event Type
    Malfunction
    Date Received
    March 19, 2009
    Date of Event
    February 18, 2009
    Report Date
    February 19, 2009
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THE LENS WAS SPLIT IN HALF AND A PIECE OF THE OPTIC WAS TORN OFF AND MISSING. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE. CONCLUSION: (OTHER) - BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST LIKELY CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO THE OFF-LABEL USE OF THE CARTRIDGE WITH THIS MODEL 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 TRAILING HAPTIC OF AN AQ2015A BENT AS THE SURGEON WAS INSERTING THE LENS AND IT TORE. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY. THE CUSTOMER USED THE CQ CARTRIDGE WHICH HAS NOT BEEN APPROVED BY THE MANUFACTURER FOR USE WITH THIS LENS MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR CARTRIDGE: MODEL CQ CARTRIDGE-FP| INJECTOR: MODEL MSI-TM