BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 18349600 · Received December 18, 2023

    Report

    Report Number
    3012236936-2023-03167
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Report Date
    December 18, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474610712
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS AN INDICATION THAT THE LENS WAS REMAIN IMPLANTED. SECTION E1: (B)(6). SECTION H3: OTHER 81: 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING OVD REMOVAL, WHEN THE SURGEON TILTED THE IOL, SURGEON FOUND THAT THERE WAS A REFLECTION OF THE RINGS ON THE OPTIC OF EYHANCE, WHICH SHOULDN'T APPEAR. BUT IT DIDN'T LOOK OBVIOUS WHEN VIEWING FROM THE FRONT, SO IT'S ALSO NOT CONVENTIONAL DIFFRACTIVE RINGS. ADDITIONAL INFORMATION RELEVELED THAT THE SURGEON DID MICRO-MONOVISION FOR THE PATIENT, AND THIS IS THE EYE WHICH TARGET -0.75 MYOPIA. AFTER IOL IMPLANTATION, SURGEON WAS WAITING FOR POST-OP OUTCOME TO SEE IF IOL EXCHANGE IS NEEDED. AT POST-OP FIRST VISIT(1DAY), PATIENT HAS GOOD OUTCOME AS USUAL(FAR VA 0.8/ NEAR VA J3). BUT DURING SECOND VISIT, THE NEAR VA DROP FROM J3 TO J8, AND FAR VA REMAIN 0.8, SO THE SURGEON IS PLANNING TO EXCHANGE THE IOL AT THE END OF DECEMBER. THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718786 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ICB00 05050474610712

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown