BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1304145 · Received January 7, 2009

    Report

    Report Number
    2023826-2009-00016
    Event Type
    Malfunction
    Date Received
    January 7, 2009
    Date of Event
    December 9, 2008
    Report Date
    December 11, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC AND ONE HAPTIC TORN. THE OTHER HAPTIC WAS BENT. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER.

    Description of Event or Problem · 1

    THE REPORTER STATED THE TECHNICIAN NOTED A TEAR ON THE LENS HAPTIC OF AN AQ2010V SILICONE THREE PIECE LENS PRIOR TO LOADING THE LENS. THE LENS WAS NOT USED AND THERE WAS NO PATIENT CONTACT. THE REPORTER STATED THEY FELT THE LENS WAS DEFECTIVE.

    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. AQ2010V N

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR CARTRIDGE: MODEL AQ CARTRIDGE-FP| INJECTOR: MODEL MSI-TM