BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22049039 · Received May 19, 2025

    Report

    Report Number
    3012236936-2025-000139
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 21, 2025
    Report Date
    November 14, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731660
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H3: 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 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: DEVICE DATE RETURNED TO MANUFACTURER: OCT 13, 2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEAL THAT THE HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD ADVANCED TO THE LENS STUCK IN THE CARTRIDGE. VISCOELASTIC RESIDUE WAS NOT OBSERVED TO BE EVENLY DISTRIBUTED THROUGHOUT THE CARTRIDGE INDICATING THAT AN INADEQUATE AMOUNT OF OVD MAY HAVE BEEN USED. NO ISSUES WERE OBSERVED WITH THE CARTRIDGE, LENS MODULE, DEVICE ASSEMBLY, PLUNGER ROD, AND PLUNGER ROD ADVANCEMENT. THE LENS COULD NOT BE REMOVED FROM THE CARTRIDGE; HOWEVER, IT WAS OBSERVED TO BE TORN AND DAMAGED. 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. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRELOADED MONOFOCAL LENS WAS DAMAGED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167721 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731660

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female