BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1101778 · Received August 5, 2008

    Report

    Report Number
    2023826-2008-01015
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 10, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO LENS IN UNIT CARTON. EVALUATION: A WORK ORDER SEARCH WAS PERFORMED AND THERE WAS NO SIMILAR COMPLAINT FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON FELT THERE WAS A BURR ON AN AA4203TL SILICONE PLATE LENS WITH TORIC THAT CAUSED THE CAPSULE TO TEAR WHEN THE LENS WAS INSERTED. THE LENS WAS CUT INTO PIECES TO BE REMOVED AND WAS DISCARDED. A VITRECTOMY WAS PERFORMED.

    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. AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE MODEL UNKNOWN| INJECTOR MODEL UNKNOWN