BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM

    MDR report key: 20788197 · Received November 26, 2024

    Report

    Report Number
    3012236936-2024-000300
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 26, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636101
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. 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: A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED; THEREFORE, NO ADDITIONAL CORRECTIVE ACTIONS HAVE BEEN INITIATED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) WAS FAULTY. THE CARTRIDGE TIP MADE CONTACT WITH THE PATIENT'S EYE, THERE WAS NO INJURY REPORTED. NO MEDICAL NOR SURGICAL INTERVENTIONS WERE REQUIRED. THE PROCEDURE WAS COMPLETED USING A BACK UP IOL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384354 TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown