BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1902474 · Received November 10, 2010

    Report

    Report Number
    2023826-2010-01124
    Event Type
    Injury
    Date Received
    November 10, 2010
    Report Date
    October 12, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    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), NO DEVICE FAILURE: EVALUATION CONCLUSION: BASED ON THE COMPLAINT HISTORY, THE MOST LIKELY ROOT CAUSE OF THE EVENT IS OFF LABEL USAGE OF THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED, "I RECEIVED AN ICL 2 YEARS AGO TO CORRECT A -12 MYOPIA. THE LENSES WERE AMAZING FOR SOMEONE THAT WAS NOT A CANDIDATE FOR LASER. MY PROBLEM NOW IS A CATARACT IN MY DOMINANT RIGHT EYE IS GOING TO REQUIRE REPLACING THE ICL AND MY NATURAL LENS WITH AN IOL. DURING THE INITIAL PROCEDURE, MY DOCTOR SAID THAT THE ICL MIGHT CAUSE A CATARACT DUE TO THE PROXIMITY OF THE LENS. HAS YOUR RESEARCH PRODUCED ANY FINDINGS THAT WOULD VERIFY THAT? MY SECOND QUESTION IS, SINCE I ONLY NEED MY RIGHT EYE CORRECTED, WOULD IT BE BETTER TO ONLY GET CORRECTED FOR DISTANCE LIKE THE LEFT EYE OR SHOULD I GET THE MULTI DISTANCE PREMIUM LENS TO ALLOW ME TO READ WITHOUT GLASSES?" OUR MEDICAL LIAISON CONTACTED THE PATIENT TO ADDRESS HIS CONCERNS, AND IT WAS DISCOVERED THAT THE PATIENT (B)(6) AND THEREFORE, THIS IS CONSIDERED OFF LABEL USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR CARTRIDGE: MODEL NANOPOINT, LOT NUMBER UNKNOWN| INJECTOR: MODEL NANOPOINT, LOT NUMBER UNKNOWN