BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2822864 · Received November 7, 2012

    Report

    Report Number
    2023826-2012-00863
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 12, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: UNKNOWN. SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). (B)(4): NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT, TORN MATERIAL. EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF THE LENS OPTIC AND ONE HAPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ2010V SILICONE THREE PIECE LENS AND NOTED THE FRONT HAPTIC WAS TORN. THERE WAS PATIENT CONTACT WITH THE CARTRIDGE BUT NO CONTACT WITH THE LENS. THERE WAS NO PATIENT INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE EVENT WAS DUE TO A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR INJECTOR: MODEL MSI-TM, LOT NUMBER UNK| CARTRIDGE: MODEL AQ CARTRIDGE-FP, LOT NUMBER UNK