BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 11231902 · Received January 26, 2021

    Report

    Report Number
    2648035-2021-07149
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    November 18, 2020
    Report Date
    April 7, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474635784
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: SINCE PRODUCT WAS NOT RETURNED, THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED.. MANUFACTURING RECORDS REVIEW: THERE ARE NO DISCREPANCIES FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW) RELATED TO THIS COMPLAINT. THE UNITS WERE RELEASED ACCORDING SPECIFICATION IN COMPLIANCE WITH THE PRODUCT INTENDED USE AS REQUIRED.. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A QUALITY PRODUCT DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. THERE WAS NO PATIENT CONTACT. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. THERE WAS NO PATIENT CONTACT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DCB00 PRE-LOADED DEVICE INJECTOR MALFUNCTION, SCRATCHED LENS. DURING HANDLING BUT PRIOR TO INSERTION. NO PATIENT CONTACT. NO ADVERSE EFFECT, INJURY OR SURGICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127833 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474635784

    Patients

    Seq Age Sex Outcome Treatment
    1