BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3103278 · Received May 9, 2013

    Report

    Report Number
    9614546-2013-00076
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    February 22, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER. THE LENS WAS CUT IN HALF AND APPEARS TO HAVE EVIDENCE OF OPHTHALMIC VISCOELASTIC ON IT. THE CONDITION OF THE LENS PRECLUDES FURTHER INVESTIGATION. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED DURING THE SAME PROCEDURE DUE TO AN UNSPECIFIED COMPLICATION. DURING THE EXPLANT OF THE LENS, THE ORIGINAL INCISION HAD TO BE ENLARGED. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202881 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention