BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 5095928 · Received September 22, 2015

    Report

    Report Number
    2023826-2015-01179
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 26, 2015
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIOPTER: -14.50, DEVICE EVALUATED BY MANUFACTURER? NO - LENS REMAINS IMPLANTED. (B)(4). CONCLUSIONS CODE: NO CONCLUSION CAN BE DRAWN: BASED ON THE COMPLAINT HISTORY, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: LENS WAS EXPLANTED ON (B)(6) 2015. CLAIM# (B)(4). LENS EXPLANTED, BUT NOT RETURNED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.0MM ICM120V4, -14.50 DIOPTER IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2009. LOW VAULT, REFRACTIVE CHANGE OVER TIME AND LENS OPACITY WAS OBSERVED ON (B)(6) 2015. THE LENS REMAINS IMPLANTED. SURGERY IS PENDING TO EXPLANT AND EXCHANGE FOR LONGER LENS. UNCORRECTED VISUAL ACUITY WAS 20/06 ON (B)(6) 2015. SEE MFR #2023826-2015-01180 FOR LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625638 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention