BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1233587 · Received November 17, 2008

    Report

    Report Number
    2023826-2008-01388
    Event Type
    Injury
    Date Received
    November 17, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 20, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: METHOD (OTHER): LENS WORK ORDER SEARCH. RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN AND BENT. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. BOTH SIDES OF THE LENS OPTIC AND HAPTICS WERE CHECKED FOR ROUGH/SHARP EDGES AND WERE FOUND TO BE ACCEPTABLE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVAL 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 AN AQ2010V SILICONE THREE PIECE LENS, BUT THE POSTERIOR HAPTIC WAS BENT AND WAS DIFFICULT TO POSITION IN THE LENS SAC. THE SURGEON STATED THE HAPTIC WAS STIFF. A CAPSULE TEAR OCCURRED DURING INSERTION OF THE IOL AND THERE WAS VITREOUS LOSS. THE LENS WAS REMOVED AND AN ANTERIOR VITRECTOMY WAS PERFORMED. ANOTHER THREE PIECE LENS WAS IMPLANTED. SUTURES WERE REQUIRED TO CLOSE THE INCISION.

    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 UNK Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK