BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3870562 · Received June 12, 2014

    Report

    Report Number
    9614546-2014-00155
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SECONDARY PROCEDURE (REPOSITION OF IOL). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS WERE REVIEWED. STERILIZATION BATCH WAS RELEASED AND THERE WERE NO NON-CONFORMANCES. THERE WERE NO ASSOCIATED NONCONFORMITY MATERIAL REPORTS. ENVIRONMENTAL MONITORING RECORDS SHOWED THAT THERE WERE NO ENVIRONMENTAL MONITORING RELATED NON-CONFORMANCES. THERE WERE NO PROCESS AND/OR MATERIAL CHANGES WITHIN THE PRODUCTION ORDER AND BASED ON THE MANUFACTURING RECORD REVIEW AND HISTORICAL REVIEW NO NON-CONFORMANCES ARE EXPECTED. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A ZCT400 TORIC INTRAOCULAR LENS (IOL) REQUIRED A SECONDARY PROCEDURE TO RESPOSITION IT AFTER IT ROTATED AND CAUSED THE PATIENT TO HAVE BLURRY VISION. THE PROCEDURE DID NOT REQUIRE AN INCSION ENLARGEMENT AND THE PATIENT IS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348010 TECNIS TORIC IOLS HQL ABBOTT MEDICAL OPTICS ZCT400

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention