BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INRAOCULA

    MDR report key: 1942040 · Received November 9, 2010

    Report

    Report Number
    2023826-2010-01126
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P980091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (OTHER) - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECES OF THE LENS OPTIC AND BOTH HAPTICS TORN OFF AND MISSING. THERE WAS EVIDENCE OF DARK RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED AN AA4204VF SILICONE SINGLE PIECE LENS, BUT THE INJECTOR PLUNGER OVERRODE AND TORE THE LENS. THE LENS WAS REMOVED WITH NO PT INJURY, NO ENLARGED INCISION OR SUTURES. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER INDICATED THAT THE CAUSE OF THE TORN LENS WAS MOST LIKELY DUE TO NOT HAVING BEEN LOADED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4204VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR CARTRIDGE: MODEL MTC-60C FP, LOT NUMBER: UNK| VISCOELASTIC: MODEL STAARVISC II, LOT NUMBER: UNK| INJECTOR: MODEL MSI-TR, LOT NUMBER - UNK