BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3914453 · Received July 3, 2014

    Report

    Report Number
    2023826-2014-00493
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 20, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: PER MEDICAL REVIEW - REPORTEDLY, BY A PATIENT, SHE WAS EXPERIENCING SUBJECTIVE VISUAL DISTURBANCES ("HALOS AND CLOUDINESS") DURING THE NIGHT TIME BUT SYMPTOMS WERE NOT PRESENT DURING THE DAY. LENS REMAINS IMPLANTED. DESPITE MULTIPLE ATTEMPTS NO ADDITIONAL INFORMATION WAS RECEIVED TO DATE. IT SHOULD BE NOTED THAT VISUAL DISTURBANCES HAVE BEEN IDENTIFIED AS POTENTIAL COMPLICATIONS AFTER ICL IMPLANTATION. THE OPTICAL DIAMETER OF THE ICL RANGES FROM 4.9 MM TO 5.8 MM AND THE PRECAUTIONS SECTION OF THE DFU INSTRUCTS PHYSICIANS THAT "PRIOR TO SURGERY, THE SURGEON MUST PROVIDE PROSPECTIVE PATIENTS WITH A COPY OF THE PATIENT INFORMATION BOOKLET FOR THIS PRODUCT AND INFORM THESE PATIENTS OF THE POSSIBLE BENEFITS AND COMPLICATIONS ASSOCIATED WITH THE USE OF THIS DEVICE". IT FURTHER PRECAUTIONS THAT "THE EFFECT OF PUPIL SIZE ON VISUAL SYMPTOMS IS NOT KNOWN". THE DFU INDICATES THE "SMALLER THE OPTIC DIAMETER, THE GREATER THE INCIDENCE OF SUBJECTIVE PATIENT SYMPTOMS". CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE - UNK IMPLANT DATE: UNK. EXPLANT DATE: UNK. (B)(4) - HALO; (CLOUDINESS). DEVICE EVALUATED BY MANUFACTURER? NO. LENS NOT RETURNED. (B)(4). LENS NOT RETURNED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HAD AN MICL IMPLANTABLE COLLAMER LENS IMPLANTED IN HER LEFT EYE (OS) AND TWO WEEKS AFTER THE SURGERY, THE PATIENT COMPLAINED OF HALOS AND CLOUDINESS AT NIGHT. 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
    390222 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR