BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 18081125 · Received November 6, 2023

    Report

    Report Number
    2023826-2023-04961
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Report Date
    October 9, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542106870
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A:UNK. H6 - TYPE OF INVESTIGATION - LENS WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM#:(B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS OF -10.00/2.5/107 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). A SCHEDULED LENS REMOVAL FOR AN UNKNOWN REASON WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334109 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY TMICL12.6 N/A 00841542106870

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown