BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 5161951 · Received October 20, 2015

    Report

    Report Number
    2023826-2015-01275
    Event Type
    Injury
    Date Received
    October 20, 2015
    Date of Event
    November 2, 2013
    Report Date
    September 22, 2015
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIOPTER: -12.00. DEVICE EVALUATED BY MANUFACTURER? NO, LENS NOT RETURNED. (B)(4). CONCLUSION: BASED ON THE COMPLAINT HISTORY, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4). LENS NOT RETURNED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2012. LOW VAULT WAS OBSERVED ON (B)(6) 2013. THE LENS WAS EXPLANTED ON (B)(6) 2014 AND WAS EXCHANGED FOR A LONGER LENS WITH A SIMILAR DIOPTER. THE PROBLEM WAS RESOLVED. PATIENT VISIT ON (B)(6) 2014 - UCVA WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692210 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention