BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 14554320 · Received May 31, 2022

    Report

    Report Number
    3012236936-2022-01392
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    May 17, 2022
    Report Date
    October 11, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474709928
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION UNKNOWN/ NOT PROVIDED. PER EU REGULATION 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. F EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    IN REVIEW, IT WAS NOTED THAT SECTION "D2' OF THE INITIAL MDR REPORT WAS INADVERTENTLY POPULATED WITH INCORRECT INFORMATION. THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION D2: COMMON DEVICE NAME: LENS, MULTIFOCAL INTRAOCULAR. SECTION D2: DEVICE PRODUCT CODE: MFK. ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 21ST JUNE 2022. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED WRAPPED IN GAUZE. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS CUT IN HALF. A REGION OF THE LENS WAS OBSERVED TO BE MISSING HOWEVER, BASED ON THE RETURN CONDITION OF THE LENS IT CANNOT BE DETERMINED IF THE MISSING AREA WAS TORN FROM THE LENS OR IF IT WAS CUT AWAY. A PORTION OF THE REMAINING HAPTIC COULD ALSO BE OBSERVED TO BE DETACHED. THE LENS WAS CLEANED AND NO FURTHER ISSUES WERE IDENTIFIED. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED ON THE LENS. VISUAL INSPECTION OF THE HANDPIECE REVEALED THAT IT WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. INSPECTION OF THE EXTERNAL ASSEMBLY REVEALED THAT THERE WERE NO ISSUES WHICH COULD CONTRIBUTE TO OR CAUSE THE OBSERVED ISSUES WITH THE LENS. A VIDEO PROVIDED BY THE CUSTOMER WAS ALSO EVALUATED BY A SME (SUBJECT MATTER EXPERT). THE VIDEO DISPLAYED AN IOL (INTRAOCULAR LENS), CLAIMED TO BE A TECNIS SYNERGY OPTIBLUE. A CURVILINEAR MARK CAN BE OBSERVED STARTING AT 11:00 AND ENDING PARALLEL TO THE OPTICAL CENTER. ADDITIONALLY, A SURFACE DISCONTINUITY CAN BE OBSERVED AT THE SURFACE OF THE LENS. THE COMPLAINT ISSUE WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OPTIC OF THE IOL (INTRAOCULAR LENS) WAS TORN AFTER IMPLANTATION. THE LENS WAS FULLY INSERTED AND IMMEDIATELY REMOVED AND REPLACED WITH THE SAME TYPE OF STANDBY IOL. THE INCISION WAS ENLARGED, BUT THERE WAS NO VITRECTOMY OR DELAY IN PROCEDURE. THE PATIENT FULLY RECOVERED. THE SURGEON THINKS THAT POST-OPERATIVE ASTIGMATISM WILL REMAIN AS A RESULT OF THIS INCIDENT, BUT HE CLARIFIED THAT IT IS TOO SOON TO TELL IF THERE IS A SURGICAL INDUCED ASTIGMATISM, AS IT COULD ONLY BE DETERMINED IN THE FOLLOWING 4-6 WEEKS AT THE EARLIEST. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2938403 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFR00V 05050474709928
    318907 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFR00V 05050474709928

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown