BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1903084 · Received November 15, 2010

    Report

    Report Number
    2023826-2010-01142
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (LENS FLIPPED AND INSERTED) - THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. METHOD - LENS WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS - : BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ5010V THREE PIECE SILICONE LENS. LENS FLIPPED AS IT WAS INSERTED INTO THE EYE. THE LENS WAS CUT TO REMOVE FROM EYE. NO ENLARGED INCISION AND NO SUTURE NEEDED. THERE WAS NO PT INJURY. BACKUP LENS WAS IMPLANTED. THE LENS WAS THROWN AWAY.

    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 COMPANY AQ5010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR INJECTOR: MODEL-MSI-PM, LOT NUMBER - UNK| CARTRIDGE: MODEL-AQ CARTRIDGE FP, LOT NUMBER-UNK