BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 8403793 · Received March 8, 2019

    Report

    Report Number
    2023826-2019-00364
    Event Type
    Injury
    Date Received
    March 8, 2019
    Report Date
    February 2, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CHANGED FROM (B)(6) 2019 TO (B)(6) 2019 CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    WEIGHT- UNK. ETHNICITY - UNK. RACE - UNK. DATE OF EVENT - UNK. BRAND NAME - UNK. COMMON DEVICE NAME - UNK. SERIAL NUMBER = UNK, EXPIRATION = UNK, UDI - UNK. IMPLANT DATE - UNK. PMA/501K - UNK. DEVICE MANUFACTURE DATE - UNK. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT A LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD). PIGMENT DISPERSION, IRIS TRANSILLUMINATION DEFECTS AND HIGH INTRAOCULAR PRESSURE WAS OBSERVED. IT WAS REPORTED THAT IT WAS CONTROLLED AND STABILIZED WITH 1 IOP MEDICATION. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196459 UNK UNK MTA STAAR SURGICAL COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention