BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6179654 · Received December 15, 2016

    Report

    Report Number
    2023826-2016-01772
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 15, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM AND EVALUATION CODES: RESULT CODE(S): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN AND SCRATCHED. A PIECE OF ONE HAPTIC WAS TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID. CONCLUSION CODE(S): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND PRODUCT EVALUATION, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -9.5 DIOPTER, TORE WHILE LOADING AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS USED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828857 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK| INJECTOR MODEL MSI-PF - LOT NUMBER UNK