BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1920809 · Received November 3, 2010

    Report

    Report Number
    2023826-2010-01098
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 5, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL METHOD: WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED A PIECE OF A HAPTIC WAS TORN OFF AND MISSING AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. A WORK ORDER SEARCH WAS PERFORMED AND THERE WAS NO SIMILAR COMPLAINTS FOUND. CONCLUSION (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND PRODUCT EVAL, 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 MICL12.5 IMPLANTABLE COLLAMER LENS TORE AS IT WAS INSERTED INTO THE EYE. THE LENS WAS REMOVED WITHOUT ANY PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR CARTRIDGE: MODEL NAVIGLIDE, LOT NUMBER UNK| INJECTOR: MODEL NAVIJECT, LOT NUMBER UNK