BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2961662 · Received February 14, 2013

    Report

    Report Number
    9614546-2013-00019
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    November 5, 2012
    Report Date
    January 25, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER. VISUAL EXAMINATION SHOWED A LENS THAT WAS CUT IN HALF AND APPEARS TO HAVE EVIDENCE OF VISCOELASTIC ON IT. THE CONDITION OF THE LENS PROHIBITED FURTHER VISUAL EXAMINATION. BATCH RECORDS WERE REVIEWED AND FOUND TO BE WITHIN SPECIFICATIONS. NO DEVIATIONS WERE NOTED DURING THE MANUFACTURING PROCESS. THE LENS MET PRODUCT SPECIFICATIONS WHEN RELEASE TO MARKET. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN INTRAOCULAR LENS (IOL) EXPLANTED AFTER EXPERIENCING HALOS AND GLARE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER IOL DURING THE SAME PROCEDURE. AN INCISION ENLARGEMENT WAS NOT REQUIRED AND THERE WERE NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64968 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention