BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3953926 · Received July 23, 2014

    Report

    Report Number
    2023826-2014-00542
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4) - NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT; BREAK, ICL. DEVICE EVALUATED BY MANUFACTURER? NO - 81 (OTHER): NO INFORMATION IF LENS WILL BE RETURNED. EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INJURY. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECE OF ONE HAPTIC TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, PROBABLE CAUSE OF LENS TEAR DURING INJECTION IS USER OR TECHNICAL ERROR. BUT A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE. THE LENS TORE DURING INSERTION INTO THE EYE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431677 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK