BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 8591098 · Received May 8, 2019

    Report

    Report Number
    2023826-2019-00774
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Report Date
    April 10, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT EXCESSIVELY HIGH VAULT WAS OBSERVED. PATIENT IS HAPPY WITH VISION BUT DOCTOR IS RELUCTANT TO LEAVE IT THAT WAY. BECAUSE IT IS SO DRAMATICALLY DIFFERENT THAN THE OTHER EYE, DOCTOR SUSPECTS THAT THERE IS AN ISSUE WITH THE HAPTICS CAUGHT ON IRIS OR SOMETHING. PATIENT MISSED HER LAST CHECK UP SO NO MEDICAL THERAPY HAS BEEN TRIED. PATIENT WAS DOING WELL 20/20 AND PRESSURE WAS FINE. SURGEON WAS HOPING TO CONFIRM THE VAULT AT THE 1-MONTH VISIT BUT PATIENT RESCHEDULED FOR JUNE. 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
    383225 UNK PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK N/A

    Patients

    Seq Age Sex Outcome Treatment
    1