BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21867761 · Received April 18, 2025

    Report

    Report Number
    3012236936-2025-000107
    Event Type
    Injury
    Date Received
    April 18, 2025
    Date of Event
    March 25, 2025
    Report Date
    April 18, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474715172
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5 AND A6: PATIENT INFORMATION NOT PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. SECTION E1: REPORTER TELEPHONE NUMBER: UNKNOWN/NOT PROVIDED. SECTION E1: REPORTER EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. DEVICE EVALUATION: AT THE TIME OF THE INVESTIGATION, DEVICE WAS NOT AVAILABLE FOR EVALUATION, THEREFORE NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE IMPLANTATION OF TORIC MULTIFOCAL INTRAOCULAR LENS, THE PATIENT¿S VISION DID NOT SHOW FAR VISUAL ACUITY. UPON CHECKING, A DIOPTER ERROR WAS IDENTIFIED, SO AN EXCHANGE SURGERY WAS PERFORMED. ZFW100 18 DIOPTER LENS IS REPLACED WITH ZFW100 17.5 DIOPTER LENS. THROUGH FOLLOW UP IT WAS LEARNT THAT THE SURGEON IS KEY OPINION LEADER (KOL) FOR SYNERGY IOL PRODUCT AND ALSO AN ARK MYOPIA SPECIALIST. FOR YOUNGER PATIENTS, HE CONSISTENTLY CHOOSES SYNERGY IOLS FOR SURGERY. THIS WAS AN OCCASIONAL CASE OF DIOPTER OR TARGET ERROR IN MULTIFOCAL PROCEDURES. NEVERTHELESS, EVEN IN THIS EXCHANGE SURGERY, HE HAS CONTINUED TO USE SYNERGY IOL. CURRENTLY, HIS SURGICAL OUTCOMES ARE VERY POSITIVE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681010 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. ZFW100 05050474715172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention