BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2963956 · Received February 15, 2013

    Report

    Report Number
    9614546-2013-00023
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. THE IOL HAD BEEN CUT DOWN THE MIDDLE AND ONE HAPTIC WAS DISTORTED; THERE WAS EVIDENCE OF VISCOELASTIC ON THE IOL. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PRIOR TO RELEASE TO MARKET THE IOL MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A TORN CAPSULE DURING THE IMPLANT OF AN INTRAOCULAR LENS. THE CAPSULE TEAR WAS ATTRIBUTED TO THE PATIENT'S ANATOMY; THERE WAS NOT A QUALITY ISSUE CONCERNING THE LENS. THE DOCTOR DECIDED TO IMPLANT AN ANTERIOR CHAMBER LENS IN THE SULCUS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68043 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention