BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2964028 · Received February 15, 2013

    Report

    Report Number
    2023826-2013-00129
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. NO KNOWN DEVICE PROBLEM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: NO. LENS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE REPORTER INDICATED THE ORIGINAL INFORMATION REPORTED WAS NOT ACCURATE INFORMATION. THE LENS IN THIS REPORT WAS IMPLANTED WITH NO PROBLEM AND REMAINS IMPLANTED. ALL IS WELL WITH THE IMPLANTED LENS.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2013. AT THE THIRD DAY POST-OP, THE IOP WAS ELEVATED AT 70 AND THE PATIENT WAS GIVEN MEDICATION. THE IOP CAME DOWN TO 30 AND THE ANGLE WAS NARROW/CLOSED. THE IRIS WAS STUCK/ WITH THE IRIS TOUCHING THE CORNEA SUPERIORLY. THE PI WAS PATENT AND THE ANTERIOR CHAMBER WAS FLAT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66490 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM125V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK