BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 16433014 · Received February 23, 2023

    Report

    Report Number
    2023826-2023-00709
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    September 8, 2022
    Report Date
    February 21, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 VICM5_12.6; -07.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) (B)(6) 2022. THE LENS HAD TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. ON THIS SAME DATE IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS AND THIS RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935206 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5_12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention CARTRIDGE MODEL-SFC-45, LOT#-1573928| FOAM TIP PLUNGER MODEL-FTP, LOT#-1574970| INJECTOR MODEL-MSI-PF, LOT#-UNK