BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS EYHANCE

    MDR report key: 12678266 · Received October 21, 2021

    Report

    Report Number
    2020664-2021-07799
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    September 24, 2021
    Report Date
    October 21, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    HQL
    UDI-DI
    05050474610910
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT AND ETHNICITY: UNKNOWN / NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE LENS REMAINS IMPLANTED. INITIAL REPORTER PHONE NO.: (B)(6). THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS THE LENS REMAINS IMPLANTED; 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A 15-DAY POST-OP VISIT A PATIENT WHO HAD BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS COMPLAINED ABOUT LOSS OF VISION COMPARED TO VISION ON THE 1ST WEEK. DURING EXAMINATION, THE SURGEON NOTICED CALCIFICATION ON ANTERIOR SIDE AND/OR IN THE IOL. IT WAS STATED THAT THE CALCIFICATION IS MORE DRAMATIC IN OS (LEFT EYE) AND HAS JUST STARTED FROM PERIPHERY IN OD (RIGHT EYE). REPORTEDLY, THE PATIENT HAS PEX (PSEUDOEXFOLIATION) SYNDROME + CLOSE ANGLE GLAUCOMA AS PRE-OP CONDITION. ADDITIONAL INFORMATION PROVIDED INDICATED THAT A WHITE SHELL-LIKE MEMBRANE OCCURRED ON THE LEFT EYE LENS AND THE SURGEON STARTED CORTISONE TREATMENT. SINCE THE OPTICAL AXIS HAS NOT BEEN AFFECTED YET, THE PATIENT CAN SEE 0.6 HOWEVER IF AXIS IS COVERED THEN THE VISION WILL BE GONE. SINCE PATIENT HAS PEX, THE SURGEON ASSUMES THERE MAY BE A REACTION. IT WAS CONFIRMED THAT THE PATIENT HAS NO DEBILITATING CONDITION. THE SURGEON ALSO STARTED STEROIDS TREATMENT WHICH THE PATIENT IS BETTER AFTER MEDICAL TREATMENT. CALCIFICATION STARTED TO BECOME THINNER AND DETACHED. THE PATIENT VISION IMPROVED FROM 0.6 TO 0.8. THE PATIENT IS TO VISIT HER DOCTOR FOR PROGRESS CHECK. THE DOCTOR BELIEVES THIS IS A PATIENT RELATED SITUATION DUE TO PEX. NO PRODUCT IS AVAILABLE FOR RETURN AS THE LENSES REMAIN IMPLANTED. NO SURGICAL INTERVENTIONS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS EMDR REPORT IS FOR THE RIGHT EYE OF THE PATIENT. A SEPARATE REPORT WILL BE FILLED FOR THE LEFT EYE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568098 TECNIS EYHANCE INTRAOCULAR LENS HQL AMO MANUFACTURING NETHERLANDS ICB00 05050474610910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention