BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 14179519 · Received April 21, 2022

    Report

    Report Number
    3012236936-2022-01063
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Report Date
    July 29, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636668
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED IN THE EYE. INITIAL REPORTER NAME AND ADDRESS: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DCB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: RETURNED TO MANUFACTURER: YES. SECTION D9: DATE RETURNED TO MANUFACTURER: MAY 6, 2022. SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: NO INTRAOCULAR LENS (IOL) WAS RECEIVED. THE COMPLAINT SIMPLICITY WAS RECEIVED INSIDE OF A BAG. A VIDEO OF THE SURGERY WAS RECEIVED AS PART OF THIS COMPLIANT. NO ADDITIONAL MATERIALS WERE RECEIVED AS PART OF THIS RETURN. NO PRODUCT EVALUATION COULD BE PERFORMED ON THE IOL AS NO IOL WAS RECEIVED. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. THE EXTERNAL ASSEMBLY WAS INSPECTED AND NO ISSUES WERE IDENTIFIED. THE HANDPIECE WAS DISASSEMBLED AND THE ASSEMBLY WAS INSPECTED; NO ASSEMBLY ISSUES WERE OBSERVED. THE CUSTOMER PROVIDED MOVIE WAS EVALUATED BY A JOHNSON & JOHNSON SUBJECT MATTER EXPERT (SME), WHO DETERMINED THAT "AN IRREGULARITY IN THE ANTERIOR SURFACE OF THE OPTICAL PORTION OF THE LENS, LOCATED IN THE MID PERIPHERY OF THE LENS AT 11:00 WHICH MEASURES APPROXIMATELY .70 X .15MM IS OBSERVED AND THE OBSERVED PHENOMENA APPEARS TO BE COMPATIBLE WITH AN IOL DENT". FURTHERMORE, "THE ROOT-CAUSE AND POTENTIAL CLINICAL IMPACT OF THE OBSERVED PHENOMENA CANNOT BE DETERMINED FROM A VIDEO ASSESSMENT". 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. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CENTER OF THE OPTIC OF AN INTRAOCULAR LENS (IOL) WAS FOUND TO BE DENTED WHEN VISCOELASTIC AGENT WAS REMOVED WITH IRRIGATION/ASPIRATION (IA) JUST AFTER IMPLANTATION. THE DENT WHICH DENT SEEMED LIKE A LENS SCRATCH WAS OBSERVED NEAR THE CENTER OF THE LENS IN A SLIT LAMP EXAMINATION ON THE FOLLOWING DAY. ALTHOUGH THE PATIENT¿S VISUAL ACUITY HAD BEEN IMPROVING, THE PHYSICIAN DECIDED TO FOLLOW UP THE PATIENT FOR ONE WEEK. REMOVING OF THE LENS COULD BE CONSIDERED DEPENDING ON THE PATIENT'S SITUATION. REPORTEDLY, THERE WAS NO ABNORMALITY DURING IMPLANTATION. THE LENS REMAINS IMPLANTED AS OF TO DATE AND NO PATIENT INJURY WAS REPORTED. OUTCOME OF PATIENT 1 WEEK AFTER SURGERY: VISUAL ACUITY IS 1.0 WITH CORRECTION. IT WAS INDICATED THAT CURRENTLY, THERE ARE NO SYMPTOMS SUCH AS INFLAMMATION AND THEY ARE TAKING A WAIT-AND-SEE APPROACH. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957337 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636668

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown