BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 15975199 · Received December 14, 2022

    Report

    Report Number
    2023826-2022-04411
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    September 8, 2022
    Report Date
    November 14, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 13.2MM VICM5 13.2 OF -10.50 DIOPTER IMPLANTABLE COLLAMER LENS TORE/BROKE DURING LOADING ON (B)(6) 2022. THE LENS WAS NOT IMPLANTED INTO THE PATIENTS RIGHT YE (OD). A REPLACEMENT LENS OF THE SAME MODEL/SIZE AND DIOPTER WAS IMPLANTED ON (B)(6) 2022 AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052360 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female CARTRIDGE MODEL: SFC-45: LOT# 1573942| FOAM TIP PLUNGER (FTP), LOT# 1577182| INJECTOR MODEL: MSI-PF, LOT# UNK