BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 9131320 · Received September 27, 2019

    Report

    Report Number
    2023826-2019-01792
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Report Date
    August 28, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00841542103299
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODE 3191 CORRECTED TO PATIENT CODE 2692 IN INITIAL MDR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Description of Event or Problem · 1

    A COMPLETED LAF CARD FOR A 13.2MM, MICL13.2, -10.0 DIOPTER, INTRAOCULAR LENS WAS RETURNED BACK TO US. NOTE ON THE LAF CARD INDICATED " LENS DIDNT SET CORRECTLY IN EYE". 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
    923547 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 13.2 N/A 00841542103299

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention