BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2832631 · Received November 14, 2012

    Report

    Report Number
    2023826-2012-00915
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC) WITH TORIC OPTIC. (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 AA4203TL TORIC SILICONE SINGLE PIECE LENS AND THE LENS TORE ADVANCING THROUGH THE CARTRIDGE. THE LENS WAS INSERTED AND WAS CUT OUT OF THE EYE WITH NO PATIENT INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE EVENT WAS DUE TO A LOADING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR INJECTOR: MODEL MSI-TR, LOT NUMBER UNK| CARTRIDGE: MODEL MTC-60C FP, LOT NUMBER UNK