BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2438472 · Received January 12, 2012

    Report

    Report Number
    2023826-2012-00029
    Event Type
    Malfunction
    Date Received
    January 12, 2012
    Date of Event
    November 21, 2011
    Report Date
    December 15, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSIONS: (USER EVENT CAUSED EVENT). THE PRODUCT PERTAINING TO THIS CLAIM WAS NOT RETURNED FOR EVALUATION. BASED ON THE COMPLAINT HISTORY, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO TECHNICAL ERROR. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON USED A MICL 13.2MM IMPLANTABLE COLLAMER LENS. THE SURGEON WAS ADVANCING THE LENS IN THE INJECTOR WHEN HE STARTED ADVANCING IT TO FAST/SOON. THE TIP OF THE CARTRIDGE HAD PATIENT CONTACT, BUT THE LENS DID NOT TOUCH THE EYE. THE SURGEON DECIDED TO USE THE BACKUP LENS, SAME MODEL AND SIZE. THERE WAS NO PATIENT INJURY. REPORTER STATED THIS EVENT WAS DUE TO SURGEON'S ERROR. THE LENS WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NAVIJECT: CARTRIDGE MODEL, LOT NUMBER UNK| NAVIJECT: INJECTOR MODEL, LOT NUMBER UNK