BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1062454 · Received June 19, 2008

    Report

    Report Number
    2023826-2008-00851
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 28, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (NO PRODUCT MALFUNCTION), EVAL: RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. BOTH SIDES OF THE LENS OPTIC AND HAPTICS WERE CHECKED FOR ROUGH/SHARP EDGES AND WERE FOUND TO BE ACCEPTABLE. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSION: BASED ON THE COMPLAINT HISTORY AND THE EVAL OF THE RETURNED PRODUCT, THE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE NOT LENS RELATED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AND REMOVED AN AA4204VL SILICONE SINGLE PIECE LENS WITHIN THE SAME SURGERY DUE TO A CAPSULE TEAR. THE LENS WAS REMOVED WITH NO PT INJURY, NO ENLARGED INCISION AND A VITRECTOMY WAS PERFORMED. A THREE PIECE LENS WAS IMPLANTED AND A SUTURE WAS REQUIRED TO CLOSE THE INCISION. THE REPORTER STATED THE CAPSULE TEAR WAS NOT LENS-RELATED AND THIS FACILITY USES A COMPETITOR'S PHACOEMULSIFICATION SYSTEM. THE REPORTER STATED THERE WAS NO APPARENT DAMAGE TO THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4204VL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR MODEL MSI-TR- LOT#: UNK| CARTRIDGE MODEL MTC-60C FP - LOT#UNK