BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11344351 · Received February 18, 2021

    Report

    Report Number
    2648035-2021-07284
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 19, 2021
    Report Date
    September 1, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531758
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA THIS FOLLOW-UP REPORT IS TO CORRECT INFORMATION PROVIDED IN SECTION B3, E1, E2, AND E3 OF THE INITIAL SUBMISSION. THE FOLLOWING IS THE CORRECT INFORMATION. SECTION B3 DATE OF EVENT, SHOULD HAVE BEEN LEFT BLANK AS THAT INFORMATION WAS NOT PROVIDED TO JJSV AND IS UNKNOWN. SECTION E: INITIAL REPORTER: THE PHYSICIAN'S NAME AND PROFESSION WAS KNOWN AT THE TIME OF THE INITIAL REPORT, HOWEVER WAS INADVERTENTLY NOT ENTERED. SECTION E1: TITLE: DR. SECTION E1 FIRST/GIVEN NAME: SHOULD HAVE BEEN LEFT BLANK, THE PHYSICIAN'S FIRST NAME WAS NOT PROVIDED. . SECTION E1 LAST NAME: HAAS. SECTION E2 HEALTH PROFESSIONAL? YES SECTION E3 OCCUPATION: HEALTHCARE PROFESSIONAL ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED; GIVE DATE: NOT APPLICABLE AS THE INTRAOCULAR LENS WAS NOT IMPLANTED. IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS LENS WAS NOT IMPLANTED. THE INTRAOCULAR LENS (IOL) 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 HISTORY RECORD, LABELING, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) HAPTIC LOOKED BENT. THERE WAS PATIENT CONTACT WITH THE CARTRIDGE ONLY. LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239740 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531758

    Patients

    Seq Age Sex Outcome Treatment
    1 1MTEC30 CARTRIDGE LOT# UNKNOWN