BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1932141 · Received December 8, 2010

    Report

    Report Number
    2023826-2010-01242
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    June 2, 2009
    Report Date
    November 12, 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
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) OTHER (LENS FLIPPED). EVALUATION METHOD - (OTHER) LENS WORK ORDER SEARCH. RESULTS - (OTHER): A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ2010V THREE PIECE SILICONE LENS. THE LENS FLIPPED DURING INSERTION INTO THE EYE. THE LENS WAS CUT TO REMOVE FROM EYE. THERE WAS NO PT INJURY. THE LENS WAS DISCARDED. A COMPETITOR'S LENS WAS IMPLANTED.

    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 45 YR CARTRIDGE: MODEL - AQ CARTRIDGE-FP - LOT # UNK| INJECTOR: MODEL - MSI-TM - LOT NUMBER - UNK