BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 20245528 · Received September 18, 2024

    Report

    Report Number
    20245528
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    May 3, 2024
    Report Date
    June 6, 2024
    Manufacturer
    JOHNSON JOHNSON SURGICAL VISION, INC.
    Product Code
    MJP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    LENS WAS JAMMED COULD NOT GET OUT. REPORTED & RETURNED TO SUPPLIER. RGA# [REDACTED], TRK# [REDACTED]. MANUFACTURER RESPONSE FOR IOL, (BRAND NOT PROVIDED) (PER SITE REPORTER). ISSUED RGA# 2[REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360196 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP JOHNSON JOHNSON SURGICAL VISION, INC. DIU375

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male