BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1222072 · Received November 6, 2008

    Report

    Report Number
    2023826-2008-01349
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 9, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED A REDDISH RESIDUE ON THE LENS AND A PIECE OF A HAPTIC PLATE WAS TORN OFF AND MISSING. BOTH SIDES OF THE OPTIC/HAPTIC WERE CHECKED FOR SHARP/ROUGH EDGES AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AA4204VL SILICONE PLATE LENS AND THE PATIENT'S CAPSULE TORE UPON INSERTION. THE LENS WAS REMOVED, A VITRECTOMY WAS PERFORMED AND AN ACL WAS IMPLANTED. THE REPORTER STATED THE PATIENT WAS TAKING FLOMAX WHICH MAKES THE IRIS FLOPPY AND DIFFICULT TO PERFORM CATARACT SURGERY. THIS INFORMATION WAS NOT DISCLOSED PRIOR TO SURGERY. CONSEQUENTLY, THE REPORTER STATED THE INCIDENT WAS DUE TO THE CONDITION OF THE PATIENT'S EYE AND NOT RELATED TO ANY OF STAAR'S PRODUCTS.

    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 UNK Required Intervention CARTRIDGE: MODEL MTC-60CFP| STAARVISC II| INJECTOR: MODEL MSI-TR