BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 7449711 · Received April 22, 2018

    Report

    Report Number
    2648035-2018-00573
    Event Type
    Malfunction
    Date Received
    April 22, 2018
    Date of Event
    April 14, 2017
    Report Date
    June 6, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531765
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED; GIVE DATE: UNKNOWN IF LENS WAS IMPLANTED. IF EXPLANTED; GIVE DATE: UNKNOWN IF LENS WAS IMPLANTED/EXPLANTED. AN ATTEMPT WAS MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF THIS EVENT, IT WAS FOUND THAT THE LENS WAS OPENED BUT NOT USED WHICH INDICATES THAT THERE WAS NO PATIENT CONTACT. THIS INFORMATION DEEMS THE FILE NOT REPORTABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS WAS BENT. IT IS UNKNOWN IF THERE WAS PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292379 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. ZCB00 05050474531765

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR