BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 15342343 · Received September 1, 2022

    Report

    Report Number
    2023826-2022-02895
    Event Type
    Injury
    Date Received
    September 1, 2022
    Report Date
    August 3, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542106238
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE: (B)(6) 2024. NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 12.6MM TMICL 12.6 IMPLANTABLE COLLAMER LENS OF -5.50/2.0/127 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS REMOVED DUE TO SIZE. THE LENS WAS REPLACED ON AN UNKNOWN DATE WITH ANOTHER STAAR LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202187 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY TMICL 12.6 NA 00841542106238

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention