BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 13040267 · Received December 19, 2021

    Report

    Report Number
    3012236936-2021-00311
    Event Type
    Malfunction
    Date Received
    December 19, 2021
    Report Date
    February 21, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636699
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANT DATE: GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED; THEREFORE, IT WAS NOT EXPLANTED. (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) HAS 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

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT ALTHOUGH "G4" WAS ADDRESSED IN THE SECTION H10 OF THE INITIAL MDR; HOWEVER, THIS FIELD STILL WAS INADVERTENTLY POPULATED WITH THE PMA# P980040 WHICH IS INCORRECT AS THAT FIELD SHOULD HAVE REMAINED EMPTY; THEREFORE, THIS IT BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT. ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: RETURNED TO MANUFACTURER: YES. SECTION D9: DATE RETURNED TO MANUFACTURER: JAN 10, 2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE COMPLAINT SIMPLICITY WAS RECEIVED IN A PLASTIC BAG. NO OTHER PRODUCT WAS RECEIVED. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE INSIDE OF THE CARTRIDGE AND THE LENS MODULE. FURTHER INSPECTION REVEALED THAT THERE WAS A LENS STUCK INSIDE OF THE CARTRIDGE. THE HANDPIECE WAS DISASSEMBLED AND THE ASSEMBLY WAS INSPECTED, PRESENTING WITH PLUNGER ROD DAMAGE. NO FURTHER ASSEMBLY ISSUES WERE IDENTIFIED. THE LENS WAS REMOVED AND CLEANED, PRESENTING WITH A DETACHED HAPTIC AS WELL AS COSMETIC ISSUES. FURTHERMORE, THE DETACHED HAPTIC MAY BE ATTRIBUTED TO AN EXCESSIVE AMOUNT OF (OVD) OPHTHALMIC VISCOELASTIC DEVICE (SHIFTING THE SEATING OF THE LENS IN THE MODULE), SUGGESTED BY THE PRESENCE OF VISCOELASTIC RESIDUE INSIDE OF THE LENS MODULE AND HANDPIECE. COMPLAINT ISSUE CANNOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING ISSUE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRAILING HAPTIC OF AN INTRAOCULAR LENS (IOL) WAS TORN TO REMAIN IN ITS INJECTOR WHEN THE INJECTOR WAS BEING PREPARED, WHICH MADE IT IMPOSSIBLE FOR THE LENS TO BE IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE BACK-UP. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938791 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636699

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown