BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13578411 · Received February 22, 2022

    Report

    Report Number
    3012236936-2022-00384
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    December 1, 2021
    Report Date
    February 22, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474606944
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WEIGHT IS 112 UNKNOWN IF THAT¿S POUNDS OR KILOGRAMS. ETHNICITY: INFORMATION UNKNOWN/NOT PROVIDED. THE DEVICE HAS NOT RETURNED FOR EVALUATION. THEREFORE, A VISUAL 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA. THIS IS TO CORRECT THE INITIAL MEDWATCH 3012236936-2022-00384 SECTION H6 HEALTH EFFECT - IMPACT CODE, SHOULD HAVE INCLUDED THE CODE 4631-MORE COMPLEX SURGERY CODE. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION H6 HEALTH EFFECT - IMPACT CODE: 4631-MORE COMPLEX SURGERY. 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 FULLY IMPLANTED IN THE PATIENT'S LEFT EYE WHEN IT WAS NOTICED THE VITREOUS WAS LEAKING FROM THE EYE. THE IOL WAS REMOVED AND A VITRECTOMY WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH A 3-PIECE J&J LENS. THE REPLACEMENT LENS MODEL AND DIOPTER ARE UNKNOWN. THE CUSTOMER THINKS THIS IS A RESULT OF A NEW PHYSICIAN ACCIDENTALLY TEARING THE BAG. REPORTEDLY, THERE WAS NO PATIENT INJURY. THROUGH FOLLOW-UP THE CUSTOMER CONFIRMED THERE WAS A CAPSULE TEAR AND NO SUTURES WERE REQUIRED. NO MEDICATIONS OUTSIDE THE REGULAR STANDARD OF CARE WERE PRESCRIBED. THE CUSTOMER ALSO STATED THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148047 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXT375 05050474606944

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention