BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1052663 · Received May 22, 2008

    Report

    Report Number
    2023826-2008-00718
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 30, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF THE LENS OPTIC AND ONE HAPTIC TORN OFF. A CARTRIDGE WAS RETURNED WITH NO VISIBLE DAMAGE. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, THE LIKELY ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO A LOADING ERROR. IT SHOULD BE NOTED THAT THE INJECTOR WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AND REMOVED AN AQ2003V SILICONE THREE PIECE LENS DUE TO THE HAPTIC BREAKING WHILE LOADING INTO THE CARTRIDGE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER SAME TYPE LENS WAS IMPLANTED. SUTURES WERE REQUIRED TO CLOSE THE INCISION. THE REPORTER STATED THE CAUSE OF THE DAMAGED IOL WAS DUE TO LOADING OF THE LENS INTO THE CARTRIDGE.

    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. AQ2003V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR MODEL MSI-TM - LOT#UNK| CARTRIDGE MODEL AQ CARTRIDGE-FP LOT#1235073