BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2150720 · Received June 22, 2011

    Report

    Report Number
    2023826-2011-00540
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 26, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND LOOP HAPTIC IS BENT. THERE WAS EVIDENCE OF DARK SURGICAL RESIDUE ON LENS SURFACE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. (B)(4).

    Description of Event or Problem · 1

    THE RPTR STATED THE SURGEON ATTEMPTED TO USE A AQ5010V THREE PIECE SILICONE LENS. NOTICED LOOP HAPTIC WAS BENT WHEN TAKEN OUT OF THE PACKAGE. ATTEMPTED TO LOAD THE LENS AND STRAIGHTEN OUT THE LOOP HAPTIC. DECIDED NOT TO USE THE LENS. THERE WAS NO PT CONTACT. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. RPTR STATED LENS WAS RECEIVED 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. AQ5010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL AND LOT NUMBER - UNK| INJECTOR: MODEL AND LOT NUMBER - UNK