BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 11122218 · Received January 6, 2021

    Report

    Report Number
    2023826-2021-00090
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 3, 2020
    Report Date
    December 11, 2020
    Manufacturer
    STAAR SUGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    123830-2604, UNK, UNK, UNK. THIS PRODUCT IS NOT MARKETED IN THE US. WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM# 718336.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT A 13.7MM, VTICM5_13.7, -3.00/0.5/173 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS DAMAGED DURING THE LOADING PROCESS. THE LENS HAD NO CONTACT WITH THE EYE. THE DOCTOR IMPLANTED A STAND BY LENS INSTEAD. PROBLEM RESOLVED, PATIENT IS HAPPY. CAUSE OF EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24743 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SUGICAL COMPANY VTICM5_13.7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK| INJECTOR MODEL: MSI-PF, LOT# UNK