BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1952670 · Received January 4, 2011

    Report

    Report Number
    2023826-2011-00003
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AA4203TF TORIC OPTIC SILICONE SINGLE PIECE LENS. AFTER LENS INSERTION, NOTICED A PIECE OF OPTIC MISSING. LENS WAS CUT TO REMOVE FROM THE EYE. THERE WAS NO PATIENT INJURY. 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 INJECTOR MODEL MSI-PR, LOT NUMBER UNK| CARTRIDGE MODEL MTC-60C FP, LOT NUMBER UNK