BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1901413 · Received November 3, 2010

    Report

    Report Number
    2023826-2010-01108
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 21, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCISION SUTURED.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AA4203TF TORIC OPTIC SILICONE SINGLE PIECE LENS. LENS TORE ON INSERTION INTO THE EYE. LENS WAS CUT TO REMOVE FROM THE EYE. THE INCISION WAS ENLARGED AND SUTURES WERE USED TO CLOSE THE WOUND. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4203TF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention INJECTOR: MODEL MSI-PR, LOT NUMBER - UNK| CARTRIDGE: MODEL MTC-60C FP, LOT NUMBER - UNK