BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 6682696 · Received June 30, 2017

    Report

    Report Number
    2648035-2017-01192
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    June 1, 2017
    Report Date
    August 2, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474530713
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: PMA# IN THE INITIAL MDR AN INCORRECT PMA/510(K) NUMBER WAS ENTERED. THE CORRECT PMA NUMBER FOR THE REPORTED DEVICE IS P880081. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 6/14/2017. DEVICE RETURNED TO MANUFACTURER ¿ YES. PRODUCT EVALUATION: ACCORDING TO THE INITIAL REPORT LENS WAS REMOVED DUE TO PATIENT HAS NO SUPPORT FOR LENS. THIS REMOVAL WAS DUE TO PATIENT CONDITION AND THERE IS NO COMPLAINT AGAINST THE LENS THEREFORE PRODUCT TESTING EVALUATION WILL NOT BE PERFORMED. DEVICE EVALUATION: THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURING SITE. ACCORDING TO THE INITIAL REPORT LENS WAS REMOVED DUE TO PATIENT NOT HAVING SUPPORT FOR LENS. THIS REMOVAL WAS DUE TO PATIENT CONDITION AND THERE IS NO COMPLAINT AGAINST THE LENS THEREFORE PRODUCT TESTING EVALUATION WILL NOT BE PERFORMED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE DEVICE. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE LENS WAS INSERTED AND REMOVED. .ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF A Z9002 21.0 DIOPTER INTRAOCULAR LENS (IOL), THE PHYSICIAN NOTICED THAT THERE WAS NO SUPPORT FOR THE LENS. THIS PATIENT WAS A POST VITRECTOMY PATIENT; VITRECTOMY WAS PERFORMED ON A DIFFERENT/PREVIOUS DAY. THE INCISION WAS ENLARGED AND LENS WAS REMOVED. NO LENS WAS IMPLANTED, PROCEDURE WAS ABORTED AND PATIENT WENT HOME APHAKIC. THE REPLACEMENT LENS HAS NOT BEEN IMPLANTED BUT THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463151 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002 05050474530713

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention