BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2002125 · Received February 2, 2011

    Report

    Report Number
    2023826-2011-00083
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 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
    MI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD (OTHER) - WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RETURNED IN LIQUID AND A PIECE OF A HAPTIC PLATE WAS TORN OFF AND MISSING. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND PRODUCT EVALUATION, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INDICATED THAT THE MICL13.2 IMPLANTABLE COLLAMER LENS, TORE EASILY AS HE WAS PULLING IT THROUGH THE CARTRIDGE WHILE LOADING. NO PATIENT CONTACT. THE SURGEON DOES NOT BELIEVE IT WAS A LOADING ISSUE, BUT CONCERNED IT WAS A FAULTY LENS.

    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 CARTRIDGE: MODEL SFC-45FP, LOT NUMBER: UNKNOWN| FOAM TIP PLUNGER MODEL, LOT NUMBER: UNKNOWN| INJECTOR: MODEL MSI-PF, LOT NUMBER: UNKNOWN