BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8629622 · Received May 21, 2019

    Report

    Report Number
    2023826-2019-00894
    Event Type
    Death
    Date Received
    May 21, 2019
    Date of Event
    April 11, 2019
    Report Date
    April 25, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE EVALUATION: LENS WAS RETURNED DRY IN A MICRO-CENTRIFUGE VIAL WITH CLEAR SURGICAL RESIDUE ON THE PRODUCT. VISUAL INSPECTION FOUND HAPTIC TORN AND RESIDUE ON LENS. LENS WAS RETURNED IN TWO PIECES. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US. NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2, -10.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. THE LENS WAS REMOVED AND REPLACED WITHIN THE SAME SURGERY DUE TO A LENS TEAR/BREAK DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT WITH THE DEVICE BUT NO PATIENT INJURY. CAUSE OF EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422700 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5 13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR CARTRIDGE MODEL: SFC-45, LOT # UNK| INJECTOR MODEL: MSI-PF, LOT # UNK