BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13803969 · Received March 18, 2022

    Report

    Report Number
    3012236936-2022-00674
    Event Type
    Injury
    Date Received
    March 18, 2022
    Report Date
    March 17, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    HQL
    UDI-DI
    05050474709744
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN/NOT PROVIDED. BEST ESTIMATE DATE IS BETWEEN 11/21/2021-2/21/2022. TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. 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 SURGEON IMPLANTED A TRIPHOBIC LENS (NON-J&J PRODUCT) IN A HYPERMETROPIC PATIENT. AS THE PATIENT WAS COMPLAINING ABOUT NEAR VISION, THE SURGEON DECIDED TO IMPLANT A SYNERGY (DFR00V) INTRAOCULAR LENS (IOL) IN THE SECOND EYE (A LENS THAT HE KNOWS AND IS HAPPY WITH NEAR VISION RESULTS), WITH THE INTENTION THAT IF THE VISION IN THIS PATIENT IS BETTER, HE WOULD EXPLANT THE TRIPHOBIC LENS OF THE FIRST EYE. THE PATIENT SAID THAT SHE SAW BETTER WITH NEAR-VISION GLASSES AND SHE NEEDED TO SEE EVEN BETTER IN THE SYNERGY (SECOND) EYE. THE SURGEON DECIDED TO EXPLANT THE LENSES FROM BOTH EYES AND REPLACED THEM WITH DIFFERENT JOHNSON & JOHNSON MODEL LENSES, AN EYHANCE AND AN EYHANCE TORIC TO THE FULL SATISFACTION OF THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822712 TECNIS IOL INTRAOCULAR LENS HQL AMO MANUFACTURING NETHERLANDS DFR00V 05050474709744

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention