BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC

    MDR report key: 791727 · Received November 21, 2006

    Report

    Report Number
    2023826-2006-01723
    Event Type
    Other
    Date Received
    November 21, 2006
    Date of Event
    October 18, 2006
    Report Date
    October 25, 2006
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    p880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON HAD INSERTED AN AA4203TL TORIC SINGLE PIECE SILICONE LENS INTO PATIENT'S EYE WITH NO PROBLEMS, HOWEVER DUE TO PATIENT HAVING A PRE-EXISTING WEAK CAPSULE, THE LENS WOULDN'T STABILIZE IN THE BAG SO THE SURGEON REMOVED THE LENS WITHOUT ENLARGING THE INCISION. ANOTHER TYPE OF LENS WAS INSERTED. THERE WAS NO COMPLAINT AGAINST THIS LENS. THIS IS THE SECOND OF TWO INCIDENTS TO OCCUR ON THIS SAME PATIENT. SEE MANUFACTURER REPORT NUMBER 2023826-2006-01724 FOR THE FIRST INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC INTRAOCULAR LENS HQL STAAR SURGICAL AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR CARTRIDGE MODEL: MTC-60CFP LOT NUMBER: UNK| INJECTOR MODEL: MSI-TR LOT NUMBER: UNK