BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 5047903 · Received September 1, 2015

    Report

    Report Number
    2023826-2015-01143
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    February 12, 2015
    Report Date
    August 4, 2015
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    NA
    Product Problem
    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). LENS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS, -8.50 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2015 AND A FOREIGN BODY WAS NOTED. ON THE SAME DAY, THE LENS WAS REMOVED AND EXCHANGED FOR ANOTHER LENS AND THIS RESOLVED THE PROBLEM. NO PATIENT INJURY WAS REPORTED. PATIENT'S LAST POST-OP UNCORRECTED VISUAL ACUITY WAS 20/20. DEVICE EVALUATION: THE LENS WAS RETURNED IN A SMALL VIAL. VISUAL INSPECTION FOUND THE HAPTIC TORN/BROKEN/BENT/DEFORMED, A PIECE OF THE HAPTIC MISSING, FOREIGN MATERIAL ON LENS SURFACE (DEBRIS), AND A SMALL PARTICULATE IN THE OPTIC VISIBLE AT 30X. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) AND A FOREIGN BODY WAS NOTED. THE LENS WAS REMOVED AND EXCHANGED FOR ANOTHER LENS AND THIS RESOLVED THE PROBLEM. NO PATIENT INJURY WAS REPORTED. PATIENT'S LAST UCVA WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578236 ICL (IMPLANTABLE COLLAMER LENS) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG VICMO13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR