BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3873146 · Received June 13, 2014

    Report

    Report Number
    2023826-2014-00451
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 21, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: MEDICAL REVIEW. RESULTS: PER MEDICAL REVIEW - IT WAS REPORTED THAT A PATIENT UNDERWENT IMPLANTATION OF A 12.6MM MICL IN THE LEFT OPTIC (OS) ON (B)(6) 2013 AND EXPERIENCED SYMPTOMS OF "LIGHT SHADOWS" FROM THE PERIPHERAL IRIDOTOMY. THE SHORT-TERM AND TRANSIENT COMPLICATIONS OF LPI INCLUDE, BUT ARE NOT LIMITED TO: BLURRED VISION, ELEVATIONS IN IOP, AND UVEITIS. THE VISUAL ABERRATIONS VARY GREATLY AMONG PATIENTS AND INCLUDE GLARE, HALOS, CRESCENTS, GHOSTING, AND SHADOWS. THE POSITION OF THE LPI SEEMS TO BE THE MAJOR FACTOR THAT DETERMINES WHETHER OR NOT THE STREAK OF LIGHT DEVELOPS AFTER THE PROCEDURE. ACCORDING TO THE DCR, DATED 06/06/2014, THE PATIENT WAS LAST SEEN ON (B)(6) 2013 AND THE EVENT WAS ONGOING BUT THE PATIENT WAS IMPROVING POST-OPERATIVELY. IN ADDITION, IT WAS REPORTED THAT THE VISUAL ACUITY WAS 20/15 POST-OPERATIVELY, AND THE PATIENT WAS "HAPPY." THE LENS REMAINS IMPLANTED. WITH THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE PATIENT'S SYMPTOMS OF DYSPHOTOPSIA IS RELATED TO THE PRODUCT, RATHER, THE SURGICAL TECHNIQUE INVOLVING THE ANGLE OF WHICH THE PROCEDURE WAS CONDUCTED. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE MEDICAL REVIEW, A POSSIBLE CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO THE SURGICAL TECHNIQUE INVOLVING THE ANGLE OF WHICH THE PROCEDURE WAS CONDUCTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO, LENS IMPLANTED. EVALUATION CODES: METHOD: WORK ORDER SEARCH. RESULTS : A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: 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

    THE PATIENT REPORTED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS IN HER LEFT EYE (OS) ON (B)(6) 2013. THE PATIENT REPORTED IS EXPERIENCING LIGHT SHADOWS FROM THE IRIDOTOMY. THE FACILITY REPORTED THE DATE OF THE LAST VISIT WAS (B)(6) 2013 AND THE EVENT WAS DUE TO THE PERIPHERAL IRIDOTOMY. THE EVENT IS ONGOING BUT IS IMPROVING. THE ICL REMAINS IMPLANTED. THE PATIENT'S VISUAL ACUITY POST-OP WAS 20/15 AND THE PATIENT IS HAPPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350856 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR