BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2492271 · Received March 13, 2012

    Report

    Report Number
    2023826-2012-00189
    Event Type
    Injury
    Date Received
    March 13, 2012
    Report Date
    March 12, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS ¿ (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PT HAD AN MICL 12.1 MM IMPLANTABLE COLLAMER LENS IMPLANTED IN THE LEFT EYE ON (B)(6) 2007. AS PART OF THE POST MARKET STUDY, THE PT REPORTED EXPERIENCING LOSS OF DISTANCE VISION OVER THE PAST YEAR. THE LENS REMAINS IMPLANTED. THE DOCTOR¿S OFFICE WAS CONTACTED FOR FURTHER INFO BUT NONE HAS BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL CO. MICL12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1