BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13091138 · Received December 27, 2021

    Report

    Report Number
    3012236936-2021-00187
    Event Type
    Injury
    Date Received
    December 27, 2021
    Report Date
    December 27, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    HQL
    UDI-DI
    05050474750746
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. BEST ESTIMATE DATE OF EVENT IS BETWEEN (B)(6) 2021. THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT WAS DISCARDED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND COMPLAINT TRENDING 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 THE MISSING INFORMATION; HOWEVER, THE INFORMATION WAS NOT AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE OPERATIVE EYE DUE TO EXCESSIVE GLARE. FURTHER FOLLOW-UP REVEALED THAT THE REPLACEMENT LENS WAS A COMPETITOR LENS AND THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES DONE. PATIENT WAS REPORTEDLY DOING EXCELLENT POST-OPERATIVELY. THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985897 TECNIS IOL INTRAOCULAR LENS HQL AMO MANUFACTURING NETHERLANDS DFR00V 05050474750746

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention