BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY IOL

    MDR report key: 15109058 · Received July 26, 2022

    Report

    Report Number
    3012236936-2022-01999
    Event Type
    Injury
    Date Received
    July 26, 2022
    Date of Event
    May 15, 2021
    Report Date
    October 27, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474652729
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION CANNOT BE PROVIDED DUE TO LOCAL PERSONAL DATA PRIVACY LEGISLATION/POLICY. REPORTER PHONE NUMBER: (B)(6). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT THE CODE 4756 (APPROPRIATE TERM/CODE NOT AVAILABLE) WAS INADVERTENTLY ENTERED IN SECTION H6 (COMPONENT CODES) INSTEAD OF 4755 AND THAT ALSO "EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS" WAS ENTERED IN THE SECTION D2 (COMMON DEVICE NAME) OF THE INITIAL MDR REPORT WHICH IS INCORRECT. THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION D2: COMMON DEVICE NAME: LENS, MULTIFOCAL INTRAOCULAR. SECTION H6: COMPONENT CODES: 4755. ADDITIONAL INFORMATION SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: AUG 12, 2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THE LENS WAS RETURNED CUT IN HALF. NO DEFECTS THAT COULD CONTRIBUTE TO VISUAL ISSUES WERE OBSERVED. NO ADDITIONAL DEFECTS WERE OBSERVED. CONCLUSION: THE COMPLAINT ISSUES WERE 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE AS THE PATIENT COMPLAINED ABOUT FAR VISION. EMMETROPIA WAS TARGETED FOR IOL POWER, BUT POST-OP REFRACTION WAS SPHERE -1.75, CYLINDER -0.5 WHICH RESULTED IN MYOPIC REFRACTION. THE DAILY ACTIVITIES OF THE PATIENT WERE SIGNIFICANTLY AFFECTED. AS THE PATIENT COMPLAINED ABOUT DAILY DRIVING CAR DUE TO FAR VISION, LENS EXCHANGE WAS PERFORMED WITH A COMPETITOR PRODUCT. AFTER EXPLANT, THE PATIENT¿S FAR VISION IS OVER 0.8. VISION PRE-OPERATIVE: FAR: 0.8 NEAR: J4 (DECIMAL) AND VISION POST-OPERATIVE: FAR: 0.5 NEAR: J2. NO OTHER INTERVENTIONS WERE REQUIRED. PATIENT IS TEMPORARILY IMPAIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371106 TECNIS SYNERGY IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZFR00V 05050474652729

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention