BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11683781 · Received April 19, 2021

    Report

    Report Number
    2648035-2021-07625
    Event Type
    Injury
    Date Received
    April 19, 2021
    Report Date
    April 18, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. THE BEST ESTIMATE TIME WOULD BE BETWEEN 9/9/2020 AND 10/13/2020. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT WAS NOT AVAILABLE; THEREFORE, FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. THERE WAS NO SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE INCOMING PRODUCT RETURN LAB RECEIVED AN INTRAOCULAR LENS (IOL) WITH A NOTE ATTACHED STATING THE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE; HOWEVER, THE REASON WAS NOT PROVIDED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT A TECNIS PRELOADED INTRAOCULAR LENS (IOL), 29.0 DIOPTER, SERIAL NUMBER UNKNOWN, WAS IMPLANTED AT ANOTHER FACILITY. THE SAME DOCTOR WHO IMPLANTED THE LENS DID AN EXCHANGE BECAUSE THE PATIENT COMPLAINED OF BLURRY VISION AND DECREASED VISUAL ACUITY (VA). THE REPLACEMENT LENS IS THE SAME MODEL AT A HIGHER DIOPTER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584884 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention