BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3243762 · Received July 23, 2013

    Report

    Report Number
    2023826-2013-00622
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    January 8, 2011
    Report Date
    July 1, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: REPORTEDLY ICL WAS EXPLANTED FOUR YEARS POSTOPERATIVELY TO ADDRESS LOSS OF VISUAL ACUITY DUE TO DEVELOPMENT OF A CATARACT. AFTER UNEVENTFUL SURGERY A TORIC IOL WAS IMPLANTED AT THE SAME SURGERY DATE AND PROGNOSIS WAS GOOD(VA 20/25+). ACCORDING TO THE REPORT, FROM THE FACILITY, THE CATARACT WAS NOT RELATED TO THE DEVICE: NC(NUCLEAR CATARACT)/PSC(POSTERIOR SUBCAPSULAR CATARACT). NC STARTS AS AN EXAGGERATION OF THE NORMAL AGEING CHANGE INVOLVING THE LENS NUCLEUS, THEREFORE IS NOT RELATED TO THE DEVICE. PSC TYPE LIES JUST IN FRONT OF THE POSTERIOR CAPSULE AND IS ASSOCIATED WITH POSTERIOR MIGRATION OF THE EPITHELIAL CELLS OF THE NATURAL LENS, THEREFORE NOT RELATED TO THE ICL AT THE TIME OF THE IMPLANTATION THE PATIENT WAS (B)(6) AND THE VISIAN ICL, PER DFU, IS INDICATED FOR ADULTS 21-45 YEARS OF AGE. IT SHOULD BE NOTED THAT LITERATURE REPORTS THAT ONLY 1-2% OF PATIENTS DEVELOP CLINICALLY SIGNIFICANT CATARACT FOLLOWING ICL IMPLANTATION PROBABLY DUE TO PATIENT RELATED FACTORS( ESPECIALLY HIGH MYOPES AND OLDER PATIENTS). (B)(4.)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER? NO: LENS NOT RETURNED. (B)(4).

    Additional Manufacturer Narrative · 1

    PT'S WEIGHT: UNK DATE OF EVENT: UNK EXPLANT DATE: NA (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO. LENS REMAINS IMPLANTED. EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: 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. CLAIM # (B)(4). LENS REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE REPORTER INDICATED THE CATARACT DIAGNOSIS WAS MADE ON (B)(6) 2011. THE REPORTER INDICATED IT WAS A NUCLEAR SCLEROSIS/POSTERIOR SUBCAPSULAR TYPE CATARACT. THE ICL WAS EXPLANTED ON (B)(6) 2013. THE CATARACT WAS REMOVED AND AN IOL WAS IMPLANTED. THE PATIENT'S PROGNOSIS WAS GOOD AND THE VISUAL ACUITY WAS 20/25+.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SURGEON IMPLANTED A 12.1MM MICL 12.1 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2009. THE PATIENT REPORTED SHE HAS LOST VISION DUE TO THE DEVELOPMENT OF A CATARACT. THE ICL REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342714 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK