BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17233074 · Received June 29, 2023

    Report

    Report Number
    3012236936-2023-01564
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    May 31, 2023
    Report Date
    August 24, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2 AND A4: UNKNOWN; REQUESTED BUT NOT PROVIDED. SECTION D6B: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE LENS REMAINS IMPLANTED. SECTION E1: EMAIL ADDRESS: UNKNOWN; REQUESTED BUT NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DIB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE PHOTO/VIDEO DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION, IF APPLICABLE FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND 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 ON: JULY 13, 2023 SECTION H3: DEVICE EVALUATED BY MANUFACTURER¿ YES DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE ALLEGED FOREIGN MATERIAL WAS RECEIVED STUCK TO THE HANDPIECE INSERT AND WRAPPED IN CLING WRAP. THE MATERIAL WAS RELOCATED TO A SPECIMEN CUP FOR TRANSPORTATION TO ANOTHER LAB FOR FTIR TESTING. VISUAL INSPECTION OF THE HANDPIECE UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. THE HANDPIECE WAS DISASSEMBLED AND THE ASSEMBLY WAS INSPECTED, NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE COULD BE IDENTIFIED. NO FURTHER MATERIAL COULD BE IDENTIFIED INSIDE OF THE HANDPIECE AND DAMAGE INSIDE OF THE HANDPIECE COULD BE IDENTIFIED THAT WOULD INDICATE THAT THE MATERIAL RECEIVED WAS PART OF THE HANDPIECE. INSPECTION OF THE CUSTOMER PROVIDED VIDEO SHOWED THE FOREIGN MATERIAL BEING EXTRACTED FROM THE PATIENT'S EYE AT APPROXIMATELY 5 MINUTES AND 50 SECONDS. A MATERIAL ANALYSIS REPORT WAS REQUESTED FOR THE FOREIGN MATERIAL. PER THE LABORATORY, THE BULK OF THE MATERIAL IS CONSISTENT WITH A PROTEIN CONTAINING MATERIAL. THE FTIR SPECTRUM RAW DATA OUTPUT FILE GENERATED WAS THEN COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY AND DID NOT YIELD ANY RESULTS WITH AT LEAST A (B)(4) CORRELATION. THE TOP HIT WAS ¿OVD HEALON PRO¿ WITH A (B)(4) CORRELATION. AS A RESULT OF THE INVESTIGATION 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 A FOREIGN SUBSTANCE THAT RESEMBLED ACRYLIC WIRE WAS FOUND FLOATING ON AN INTRAOCULAR LENS (IOL) AFTER IMPLANTATION. THE FOREIGN SUBSTANCE WAS REMOVED BY SUCTION. THERE WAS NO REPORTED HEALTH DAMAGE AND THE PATIENT'S VISUAL ACUITY HAS BEEN GOOD. THE IOL REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866095 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown