BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2080171 · Received April 7, 2011

    Report

    Report Number
    2023826-2011-00310
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON INSERTED AN AA4203TL TORIC OPTIC SILICONE SINGLE PIECE LENS. LENS TORE DURING INSERTION INTO THE EYE. LENS WAS REMOVED WITH NO PATIENT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. REPORTER STATED LENS TEAR WAS DUE TO LOADING ERROR BY TECH.

    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. AA4203TL NA

    Patients

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