BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1932134 · Received December 7, 2010

    Report

    Report Number
    2023826-2010-01236
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Report Date
    November 8, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (OTHER) NO PRODUCT MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON USED AN AQ2010V THREE PIECE SILICONE LENS. THE CAPSULE BROKE PRIOR TO LENS INSERTION. THE SURGEON DECIDED TO INSERT LENS IN THE SULCUS. ONCE THE LENS WAS INSERTED INTO THE EYE, THE SURGEON DECIDED TO REMOVE LENS AND USE A ANTERIOR CHAMBER LENS INSTEAD. LENS WAS CUT IN HALF TO REMOVE FROM EYE. LENS WAS THROWN AWAY. REPORTER STATED, THERE WAS NO PRODUCT MALFUNCTION. THE SURGEON JUST CHANGED HIS MIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL UNK, LOT # UNK| INJECTOR: MODEL UNK, LOT # UNK