BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21939901 · Received April 30, 2025

    Report

    Report Number
    3012236936-2025-000121
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    March 19, 2025
    Report Date
    May 27, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655386
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. . SECTION E1 - TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND NO PRODUCT QUALITY DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PO. NO ESCALATION REQUIRED. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WERE FOUND. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, 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: THE FOLLOWING SECTION IS BEING ADDED ACCORDINGLY PER NEW INFORMATION RECEIVED: SECTION B5 - DESCRIBE EVENT OR PROBLEM: FURTHER FOLLOW-UP REVEALED THAT NO RESISTANCE WAS OBSERVED DURING LENS PREPARATION / ADVANCEMENT. DIRECTIONS FOR USE WERE FOLLOWED. PATIENT POST-OPERATIVELY IS GOOD. 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 TRAIL HAPTIC GOT STUCK AND BROKE AT THE NOZZLE TIP, PREVENTING IT FROM ADVANCING OUT. A REPLACEMENT LENS WAS USED INSTEAD. IT WAS MENTIONED THAT THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. PATIENT DID NOT SEEK MEDICAL ATTENTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208552 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655386

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown