BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1002512 · Received February 26, 2008

    Report

    Report Number
    2023826-2008-00267
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 9, 2008
    Report Date
    January 31, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF THE LENS OPTIC AND ONE HAPTIC TORN OFF. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. A CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, LOT NUMBER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON INSERTED A SILICONE THREE PIECE LENS AND IT WAS NOTED THAT THE CAPSULE BAG WAS TORN. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND A VITRECTOMY WAS PERFORMED. SUTURES WERE REQUIRED TO CLOSE THE INCISION. ANOTHER LENS WAS NOT IMPLANTED. THE REPORTER STATED, THIS FACILITY USES A COMPETITOR'S PHACOEMULSIFICATION SYSTEM.

    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 YR Required Intervention CARTRIDGE MODEL AQ CARTRIDGE-FP| LOT NUMBER 1233882| INJECTOR MODEL MSI-PM LOT NUMBER UNK