BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY IOL

    MDR report key: 14782261 · Received June 22, 2022

    Report

    Report Number
    3012236936-2022-01538
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    April 21, 2022
    Report Date
    June 22, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE OR DATE OF BIRTH, WEIGHT AND ETHNICITY: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SERIAL#: UNKNOWN/ NOT PROVIDED EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI #: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPLANT DATE: UNKNOWN/ NOT PROVIDED. BUT THE BEST ESTIMATE DATE IS 10 DAYS POST IMPLANT DATE OF (B)(6) 2022. TELEPHONE NUMBER: (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO 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 A REFRACTIVE SURPRISE WAS NOTED DURING THE POST OPERATIVE VISIT. ACCOUNT'S BRIEF DESCRIPTION OF THE EVENT INDICATED THAT THE 16 DIOPTER (D) IMPLANT WAS CALCULATED TO GIVE A FINAL REFRACTION OF +0.06 D. VISUAL ACUITY WAS 10/10 WITH -1.50 PRE-OPERATIVELY. AFTER THE SURGERY, THE REFRACTION WAS MEASURED AS +2.25 WITH THE AUTOMATIC REFRACTOMETER, VISUAL ACUITY WAS 1/10 P8 WITHOUT CORRECTION AND 10/10 WITH +1.75 (-0.75.55°). THE SURGEON CHECKED THAT THE IMPLANT USED WAS THE CORRECT ONE. A NEW BIOMETRIC CALCULATION ONLY FOUND A DIFFERENCE OF 0.50 D IN IMPLANT MEASUREMENT, NOT EXPLAINING THIS HYPERMETROPISATION OF AT LEAST +1.50 D. THEREFORE, THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE TEN (10) DAYS POST IMPLANTATION. THE EXPLANTED IOL WAS DISCARDED AND THE DOCTOR CONSIDERS THE ISSUE AS CLOSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329011 TECNIS SYNERGY IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZFR00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention