BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SYNERGY IOL

    MDR report key: 15407266 · Received September 12, 2022

    Report

    Report Number
    3012236936-2022-02265
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    May 9, 2022
    Report Date
    September 12, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474652606
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANT DATE: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. EXPLANT DATE: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. INITIAL REPORTER NAME AND ADDRESS: TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THE LENS WAS RECEIVED CUT IN HALF WITH BOTH HAPTICS DETACHED. FURTHERMORE, THE LENS WAS RETURNED WITH BLUE FILAMENTS ATTACHED TO THE LENS. THE LENS APPEARS TO HAVE BEEN MANIPULATED BEYOND ITS INTENDED USAGE, DESIGN, AND FUNCTION. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED AND NO NON-CONFORMANCE REPORT (NC) WAS FOUND AS PART OF THIS MANUFACTURING RECORDS REVIEW. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THE SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: THE REPORTED COMPLAINT ISSUE WAS NOT CONFIRMED. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT THERE WAS AN ERROR DURING THE CATARACT SURGERY WHILE INSERTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY REVEALED THAT THE HAPTIC AND OPTIC OF THE LENS ARE SEPARATED AND DISCHARGED DURING THE DELIVERY OF THE LENS. ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE PATIENT'S EYE. THERE WAS NO OTHER PATIENT INVOLVEMENT. THE CUSTOMER INDICATED THAT THEY USED THE DEVICE PER THE DIRECTION FOR USE (DFU). NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2392360 TECNIS SYNERGY IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. ZFR00V 05050474652606

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown