BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 9855436 · Received March 19, 2020

    Report

    Report Number
    2023826-2020-00536
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 13, 2020
    Report Date
    February 26, 2020
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542108805
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA:) B5- IN INITIAL MDR STATEMENT "THE PATIENT WAS GIVEN AN RX FOR ALPHAGAN" IS NOT APPLICABLE. THE "RX" IS REFERENCE TO EYEGLASS PRESCRIPTION PROVIDED BY THE OPTOMETRIST. PATIENT IS CONCURRENTLY TAKING ALPHAGAN OU QHS. H6: PATIENT CODE 3191: RESIDUAL REFRACTION ERROR. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -8.50/1.0/067 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. REPORTEDLY "PATIENT IS UNHAPPY WITH HER VISION." PATIENT WAS GIVEN AN RX OF ALPHAGAN P OU QHS. 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
    315948 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY TMICL13.2 N/A 00841542108805

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR