BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6126100 · Received November 23, 2016

    Report

    Report Number
    2023826-2016-01676
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 25, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED DRY IN A LENS CASE/VIAL WITH CLEAR SURGICAL RESIDUE/DEBRIS ON PRODUCT. VISUAL INSPECTION FOUND THE LENS HAD A SCRATCH. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4). LENS NOT RETURNED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICMO12.6 IMPLANTABLE COLLAMER LENS, -11.00 DIOPTER IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO LOW VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS AND PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776696 ICL (IMPLANTABLE COLLAMER LENS) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO12.6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention