BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 726480 · Received June 15, 2006

    Report

    Report Number
    2023826-2006-00756
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Date of Event
    May 15, 2006
    Report Date
    May 15, 2006
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    p880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THE LENS IS TORN IN HALF AND A PORTION OF ONE HAPTIC IS TORN OFF & MISSING. CLEAR AND REDDISH SURGICAL RESIDUE ON THE LENS. NO CONCLUSION CAN BE DRAWN. BASED ON THE COMPLAINT HISTORY AND EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION. PMA NUMBER IS P880091.

    Description of Event or Problem · 1

    THE SURGEON INSERTED A SINGLE PIECE SILICONE TORIC LENS MODEL AA4203TL INTO THE PT'S EYE AND THE LENS TORE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER MODEL LENS WITHOUT ENLARGING THE INCISION. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INTRAOCULAR LENS HQL STAAR SURGICAL AA4203TL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 2.CARTRIDGE MODEL:MTC-60C FP,LOT#:UNK| 1.INJECTOR MODEL: MSI-TR, LOT#:UNK.