BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 11213135 · Received January 22, 2021

    Report

    Report Number
    2648035-2021-07127
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    December 22, 2020
    Report Date
    March 12, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636071
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW OF SECTION E IN FOLLOW-UP 1, THE COUNTRY WAS INADVERTENTLY SELECTED AS UNITED STATES, HOWEVER, THE COUNTRY SHOULD HAVE BEEN CANADA. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA/ADDITIONAL INFORMATION: IN REVIEW, IT WAS NOTED THAT THE INITIAL REPORT WAS INADVERTENTLY SUBMITTED FOR THIS EVENT, WHICH BASED ON THE INFORMATION RECEIVED FROM THE ACCOUNT ON (B)(6) 2021, IT SHOULD NOT HAVE BEEN INITIALLY REPORTED. THE ADDITIONAL INFORMATION FROM THE ACCOUNT INDICATED THAT IN FACT, THERE WAS NOTHING FAULTY ABOUT THE LENS. ONLY THAT THE STAFF IN PLACE DID NOT KNOW HOW TO USE THE DCB00 LENS INSTEAD OF THE PCB00. THE INJECTOR IS DIFFERENT AND THE PERSON USING IT GOT CONFUSED AND THE LENS AFTER OPENING CANNOT BE USED/REUSED. BASED ON THE PROVIDED INFORMATION THE EVENT IS NO LONGER REPORTABLE AND NO ADDITIONAL INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER 2648035 -2021 -07127. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN PRELOADED LENS (DCB00) WAS DEFECTIVE LENS. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108972 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636071

    Patients

    Seq Age Sex Outcome Treatment
    1