BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 18122724 · Received November 13, 2023

    Report

    Report Number
    2023826-2023-05077
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    September 30, 2023
    Report Date
    October 18, 2023
    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

    (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.0/+3.0/090 INTO THE PATIENT'S RIGHT EYE (OD) (B)(6)2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. CAUSE REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236990 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention CARTRIDGE MODEL:SFC-45, LOT# 1669940| FOAM TIP PLUNGER (FTP), LOT# UNK| INJECTOR MODEL: MSI-PF LOT# 1664890