BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 14762220 · Received June 21, 2022

    Report

    Report Number
    3012236936-2022-01653
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    May 26, 2022
    Report Date
    September 1, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636118
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. TELEPHONE NUMBER: (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. 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. RETURNED TO MANUFACTURER ON: JUL 01, 2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS CUT IN HALF. THE LENS WAS ALLOWED TO AIR DRY AND NO FURTHER ISSUES COULD BE OBSERVED. THE ALLEGED FOREIGN MATERIAL WAS LOCATED INSIDE OF THE SPECIMEN CUP. A MATERIAL ANALYSIS REPORT REVEALED THAT THE FOREIGN SUBSTANCE TESTED IS CONSISTENT WITH A PROTEIN CONTAINING MATERIAL (E.G., SKIN FLAKES). THE FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) SPECTRUM OF THE FOREIGN SUBSTANCE WAS COMPARED AGAINST THE MANUFACTURING SITE'S PROCESS FTIR LIBRARY WHICH YIELDED NO RESULTS WITH A 0.90000 CORRELATION OR HIGHER. THE TOP HIT WAS ¿N/A1PC ALUMINUM PLATE WITH A 0.3202032 CORRELATION. THE COMPLAINT ISSUE OF "FOREIGN MATERIAL - LOOSE" WAS OBSERVED 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. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), THE SURGEON OBSERVED AN UNIDENTIFIABLE FILAMENT THAT HE WAS NOT ABLE TO REMOVE. THE SURGEON INDICATED THAT HE NOTICED A NOISE WHILE PREPARING THE INJECTOR. THE FULLY INSERTED IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. A BACK-UP LENS WAS IMPLANTED. A 15 MINUTE DELAY IN PROCEDURE WAS REPORTED; HOWEVER, NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596073 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636118

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female