BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 17076404 · Received June 6, 2023

    Report

    Report Number
    2023826-2023-02262
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    January 12, 2022
    Report Date
    May 11, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 12.1MM VTICM5_12.1 IMPLANTABLE COLLAMER LENS OF -6.50/1.0/062 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)96) 2022. LOW VAULT WITH ROTATION WAS OBSERVED. LENS REPOSITIONING WAS PERFORMED (ON (B)(6) 2022). ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THE EXCHANGE RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606311 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention