BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3040118 · Received April 3, 2013

    Report

    Report Number
    2023826-2013-00255
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    February 12, 2013
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LENS WORK ORDER SEARCH. RESULTS. OTHER: 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).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A MICL 13.2 MM IMPLANTABLE COLLAMER LENS IMPLANTED IN THE LEFT EYE. AS PART OF THE POST MARKET STUDY, THE PATIENT ANSWERED YES TO QUESTION, "HAVE YOU BEEN PRESCRIBED EYE DROPS FOR A LEAST 3 CONSECUTIVE MONTHS OR HAVE YOU HAD SURGERY BECAUSE YOUR PHYSICIAN HAD SAID THAT YOU HAVE A HIGH PRESSURE OR GLAUCOMA INSIDE THE EYE". NO FURTHER INFORMATION. THE PHYSICIAN'S OFFICE ALSO ANSWERED YES BUT NO ADDITIONAL INFORMATION WAS AVAILABLE. THE PHYSICIAN'S OFFICE WAS CONTACTED FOR ADDITIONAL INFORMATION, BUT NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE. SEE MFR. #2023826-2013-00254 FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136736 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention