BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2072676 · Received April 29, 2011

    Report

    Report Number
    2023826-2011-00360
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 8, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN, WITH A PIECE TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. (B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE®).(B)(4)

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED AN AQ2015A SILICONE ASPHERIC THREE PIECE LENS AND THERE WAS A CRACK IN THE CENTER OF THE LENS OPTIC. THE LENS WAS CUT TO REMOVE FROM THE EYE WITH NO COMPLICATIONS. THE REPORTER INDICATED THE EVENT WAS DUE TO ERROR IN FOLDING LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2015A

    Patients

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