BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 16247120 · Received January 26, 2023

    Report

    Report Number
    2023826-2023-00299
    Event Type
    Injury
    Date Received
    January 26, 2023
    Date of Event
    October 27, 2022
    Report Date
    December 29, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -8.0/+1.5/092 INTO THE PATIENT'S RIGHT EYE (OD) (B)(6) 2022. THE LENS WAS EXCHANGED ON (B)(6) 2022 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. CAUSE OF EVENT REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792704 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention CARTRIDGE MODEL: SFC-45: LOT# UNKNOWN.| FOAM TIP PLUNGER (FTP), LOT# UNKNOWN.| INJECTOR MODEL: MSI-PF, LOT# UNKNOWN.