BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6191994 · Received December 20, 2016

    Report

    Report Number
    2023826-2016-01814
    Event Type
    Injury
    Date Received
    December 20, 2016
    Report Date
    November 22, 2016
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM AND EVALUATION CODES: (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER?: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS RETURNED IN PIECES AND UNABLE TO EVALUATE. THE LENS WAS RETURNED DRY. METHOD CODE(S): LENS WORK ORDER SEARCH. RESULTS CODE(S): A WORK ORDER SEARCH FOUND NO SIMILAR COMPLAINTS WITHIN THE WORK ORDER. CONCLUSION CODE(S): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, ON (B)(6) 2009. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO THE DEVELOPMENT OF A CATARACT. THE PATIENT COMPLAINED OF BLURRY VISION AT NIGHT. THE CATARACT WAS REMOVED AND AN IOL WAS IMPLANTED. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839251 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG MICL12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK| INJECTOR MODEL MSI-PF - LOT NUMBER UNK