BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 12443631 · Received September 8, 2021

    Report

    Report Number
    2023826-2021-03484
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 11, 2021
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO: UNK. EXPLANT DATE: NA. PMA/510K: THIS PRODUCT IS MANUFACTURED IN (B)(4) BUT NOT MARKETED IN THE U.S. (B)(4). WORK ORDER SEARCH: NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM # (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VICMO12.6 IMPLANTABLE COLLAMER LENS, -04.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2013. A REFRACTIVE CHANGE OVERTIME WAS NOTED AND THE LENS REMAINS IMPLANTED. THE CAUSE OF THE EVERNT WAS DUE TO PATIENT RELATED FACTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340732 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG VICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR