BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6089943 · Received November 9, 2016

    Report

    Report Number
    2023826-2016-01603
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    August 1, 2016
    Report Date
    October 12, 2016
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS MANUFACTURED IN (B)(4) AND IS NOT MARKETED IN THE U.S. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: (OFF-LABEL USE): PATIENT ACD WAS BELOW 3.00 MM. (B)(4).

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED DRY IN CASE/VIAL; SURGICAL RESIDUE WAS CLEAR; VISUAL INSPECTION FOUND HAPTIC BROKEN; DIMENSIONAL AND FUNCTIONAL INSPECTIONS FOUND WITHIN SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -9.0/+4.0/093 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2015. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO LOW VAULTING, LENS ROTATION AND REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED FOR ANOTHER SAME MODEL BUT DIFFERENT DIOPTER LENS. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY WAS 20/23.

    Description of Event or Problem · 1

    THE PROBLEM WAS RESOLVED AFTER LENS EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740246 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG VTICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention