BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_TECNIS SYNERGY

    MDR report key: 16499631 · Received March 7, 2023

    Report

    Report Number
    3012236936-2023-00440
    Event Type
    Injury
    Date Received
    March 7, 2023
    Report Date
    March 7, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE, WEIGHT, ETHNICITY: UNKNOWN/INFORMATION NOT PROVIDED. ASKU. DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. BRAND NAME: UNKNOWN/AS THE SERIAL NUMBER WAS NOT PROVIDED. ONLY PROVIDED AS IOL SYNERGY.   MODEL NUMBER: UNKNOWN/AS THE SERIAL NUMBER WAS NOT PROVIDED. ONLY PROVIDED AS IOL SYNERGY.   CATALOG NUMBER: UNKNOWN/AS THE SERIAL NUMBER WAS NOT PROVIDED. ONLY PROVIDED AS IOL SYNERGY.   SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN/AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN/ INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN/ INFORMATION NOT PROVIDED. INITIAL REPORTER PHONE NUMBER: (B)(6). DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW CANNOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. A COMPLAINT HISTORICAL REVIEW OF THE MANUFACTURING PRODUCTION ORDER NUMBER CANNOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: NO SAMPLE WAS RETURNED, AND THE SERIAL NUMBER IS UNKNOWN, AN INVESTIGATION COULD NOT BE PERFORMED, AND NO MALFUNCTION IS CONFIRMED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. AN ATTEMPT WAS MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED ¿HALOS¿ AFTER THE SYNERGY INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN BOTH EYES. THE DOCTOR PROCEEDED TO EXPLANT THE LENSES FROM EACH EYE. THE DECISION TO EXPLANT WAS DUE TO THE PATIENT COMPLAINTS OF "DISCOMFORT¿ EXPERIENCED WHEN ¿UNABLE TO ADAPT TO THE LENSES". IT WAS REPORTED THAT THE EXPLANT WAS NOT CAUSED BY DAMAGE THAT TRIGGERED AN ADVERSE EVENT IN THE HEALTH OF THE PATIENTS. THERE IS NO EVIDENCE TO INDICATE THAT ¿NOVELTIES¿ HAVE OCCURRED DURING LENS IMPLANTATION. THE PRODUCT WILL NOT BE RETURNING. NO OTHER INFORMATION WAS PROVIDED.  PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659976 UNK_TECNIS SYNERGY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS UNK-TECNIS SYNERGY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention