BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 893445 · Received August 8, 2007

    Report

    Report Number
    2023826-2007-01363
    Event Type
    Other
    Date Received
    August 8, 2007
    Date of Event
    June 27, 2007
    Report Date
    July 11, 2007
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. 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 HAD PARTIALLY AA4204VL SILICONE SINGLE PIECE LENS AND THE PATIENT SQUEEZED THEIR EYE AND THE LENS POPPED OUT. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THE LENS WAS CONTAMINATED AND ANOTHER SAME TYPE LENS WAS IMPLANTED. THIS IS ONE OF TWO LENSES USED FOR THIS PATIENT - SEE MFR # 2023826-2007-01364.

    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 COMPANY AA4204VL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR CARTRIDGE MTC-60C FP-LOT NUMBER UNK| INJECTOR MODEL MSI-PR- LOT NUMBER UNK