BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2983510 · Received February 28, 2013

    Report

    Report Number
    2023826-2013-00176
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 4, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). LENS NOT RETURNED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE FACILITY REPORTED THE PATIENT HAD A REFRACTIVE SURPRISE (DEVELOPED HYPEROPIA WITH OVER ASTIGMATISM).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS IN HIS PATIENT AND HAS NOW REPORTED A PROBLEM WITH THE ICL. ADDITIONAL INFORMATION HAS BEEN 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
    88096 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK