BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 14921311 · Received July 5, 2022

    Report

    Report Number
    2023826-2022-02101
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 21, 2022
    Report Date
    June 30, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    H3 - DEVICE EVALUATION: LENS WAS RETURNED IN A DEVICE TRAY. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO THE LENS. THE DIMENSION OF THE RETURNED CARTRIDGE LOADING DUCK WAS FOUND TO BE WITHIN RANGE OF THE UPPER AND LOWER LIMITS. H6 - TYPE OF INVESTIGATION 3331 - DEVICE HISTORY RECORD (DHR) REVIEW: BASED ON THE RESULTS OF THE INVESTIGATION, ALL RELEASED DEVICES FROM THE ASSOCIATED WORK ORDER(S), INCLUDING THE SUSPECTED DEVICE, HAVE BEEN MANUFACTURED WITHIN ESTABLISHED PROCESS PARAMETERS AND THERE IS NO INDICATION THAT THE MANUFACTURING AND PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. H6 - TYPE OF INVESTIGATION: 4110 - LENS WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM#: (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT WHILE THE SURGEON WAS IMPLANTING AN IMPLANTABLE COLLAMER LENS; A SFC-45 CARTRIDGE WITH FOAM TIP PLUNGER HAD FAILED. IT WAS NOTED" THE PART OF THE SFC-45 WHERE THE LENS IS SET IN A MOUNTAIN FOLD (OPPOSITE OF THE NOZZLE) IS WIDER THAN OTHER SFC-45'S; MAKING IT IMPOSSIBLE TO SET THE LENS". THE LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED DUE TO ANOTHER LOT OF CARTRIDGES WERE USED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND INDICATED "WE RECOGNIZE THAT THERE ARE INDIVIDUAL DIFFERENCES IN THE SHAPE OF THE SFC-45".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449175 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CARTRIDGE MODEL-SFC-45, LOT#-1527544| FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK| INJECTOR MODEL-MSI-PF, LOT#-UNK