BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1340829 · Received January 20, 2009

    Report

    Report Number
    2023826-2009-00054
    Event Type
    Malfunction
    Date Received
    January 20, 2009
    Date of Event
    December 22, 2008
    Report Date
    December 22, 2008
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS STUCK IN THE RETURNED CARTRIDGE. THE CARTRIDGE TIP WAS DAMAGED. THERE WAS EVIDENCE OF REDDISH RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND IN THE WORK ORDER. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, AND THE EVAL OF THE RETURNED PRODUCT, A LIKELY ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE OF THE OFF-LABEL USE OF THE CARTRIDGE WITH THIS MODEL LENS. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT AN AQ2015A SILICONE THREE PIECE LENS, BUT THE PLUNGER OVERRODE AND TORE THE LENS. THERE WAS PT CONTACT WITH THE CARTRIDGE, BUT NO CONTACT WITH THE LENS. THERE WAS NO PT INJURY. THIS IS ONE OF THREE LENSES USED FOR THIS PT - SEE MFR REPORT#: 2023826-2009-00052 AND 0203826-2009-00053. THE CARTRIDGE USED HAS NOT BEEN APPROVED BY THE MFR FOR USE WITH THIS MODEL LENS.

    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 59 YR CARTRIDGE: MODEL CQ CARTRIDGE-FP| INJECTOR: MODEL MSI-TM