BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS

    MDR report key: 3830497 · Received May 23, 2014

    Report

    Report Number
    9614546-2014-00135
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OF PATIENT FIELD IS NOT COMPLETED AS THIS INFORMATION ALTHOUGH REQUESTED WAS NOT PROVIDED. PATIENT GENDER FIELD IS NOT COMPLETED AS THIS INFORMATION ALTHOUGH REQUESTED WAS NOT PROVIDED. DATE OF EVENT FIELD IS NOT COMPLETED AS THIS INFORMATION ALTHOUGH REQUESTED WAS NOT PROVIDED. EXPIRATION DATE AND SERIAL NUMBER FIELDS ARE NOT COMPLETED AS THIS INFORMATION ALTHOUGH REQUESTED WAS NOT PROVIDED. DATE OF IMPLANT AND DATE OF EXPLANT FIELDS ARE NOT COMPLETED AS THIS INFORMATION ALTHOUGH REQUESTED WAS NOT PROVIDED. DEVICE MANUFACTURE DATE FIELD IS NOT COMPLETED AS THIS INFORMATION ALTHOUGH REQUESTED WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT AS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING RECORD REVIEW WAS CONDUCTED. SERIAL NUMBER (B)(4) IS PART OF ORDER NUMBER (B)(4). ELEMENTS REVIEWED WERE THE DEVICE HISTORY RECORDS, NON-CONFORMING MATERIALS, STERILIZATION RECORDS AND ENVIRONMENTAL MONITORING RECORDS. NO NON-CONFORMANCES WERE REVEALED AND THIS ORDER NUMBER WAS NOT PRODUCED UNDER DEVIATION. IN ADDITION THERE WERE NO PROCESS AND/OR MATERIAL CHANGES WITH THIS ORDER NUMBER. A SEARCH ON COMPLAINTS RELATED TO THIS ORDER NUMBER WAS ALSO CONDUCTED AND REVEALED THAT NO OTHER COMPLAINTS FOR THIS ORDER NUMBER WERE RECEIVED TO DATE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: MODEL NUMBER PREVIOUSLY REPORTED AS ZCT100; HOWEVER, IT WAS LEARNED THE CORRECT MODEL NUMBER IS ZCT300. NEW INFORMATION NOW INDICATES AN ADVERSE EVENT IN ADDITION TO ORIGINALLY REPORTED MALFUNCTION. (B)(4). IN ADDITION IT WAS ALSO LEARNED THAT THERE WERE NO COMPLICATIONS DURING IMPLANTATION OF THE LENS INTO THE LEFT EYE. THE LENS WAS REPOSITIONED IN A SECONDARY PROCEDURE ON (B)(6) 2014. THE LENS REMAINS IMPLANTED. PLACEHOLDER.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A ZCT100 INTRAOCULAR LENS HAD ROTATED 30 DEGREES AFTER IMPLANTATION. THERE WAS INDICATION THAT THE PHYSICIAN WOULD TAKE THE PATIENT BACK TO THE OPERATING ROOM AND ROTATE THE LENS. FOLLOW UP WAS CONDUCTED HOWEVER NO ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308050 TECNIS TORIC IOLS HQL ABBOTT MEDICAL OPTICS ZCT300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention