BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 7382965 · Received March 29, 2018

    Report

    Report Number
    2023826-2018-00488
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    February 27, 2018
    Report Date
    March 1, 2018
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00841542103053
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LENS WAS RETURNED STUCK IN SFC-25 CARTRIDGE. CARTRIDGE WAS RETURNED IN DEVICE TRAY WITH CLEAR RESIDUE. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO THE DEVICE, RESIDUE ON LENS AND THE LENS STUCK IN THE CARTRIDGE. A LENS WORK ORDER SEARCH WAS PERFORMED. NO OTHER SIMILAR COMPLAINT TYPE EVENT FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA CONCOMITANT MEDICAL PRODUCTS: CARTRIDGE MODEL NO.: SFC-25 AND CARTRIDGE LOT NO.: 1380994. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: CLAIM# (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON LOADED A 12.6MM MICL12.6, IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, AND THE LENS RIPPED. THERE WAS NO PATIENT CONTACT. THE BACK UP LENS WAS USED WITH NO ISSUES. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225901 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA 00841542103053

    Patients

    Seq Age Sex Outcome Treatment
    1