BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 14723496 · Received June 16, 2022

    Report

    Report Number
    3012236936-2022-01563
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    December 2, 2021
    Report Date
    June 16, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474750746
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE ACCOUNT DID NOT PROVIDE THE INFORMATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO THE PATIENT'S VISION WAS NOT SHARP AND PATIENT WAS EXPERIENCING HALOS AND GLARE. DURING THE EXPLANT, ONE SUTURE WAS NEEDED. ANOTHER JOHNSON & JOHNSON DFW150 LENS (DIFFERENT MODEL AND 23.5 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT OUTCOME REPORTED VISION IS EXCELLENT ALTHOUGH THERE ARE HALOS AT NIGHT. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508969 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DFR00V 05050474750746

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention