BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1901425 · Received November 2, 2010

    Report

    Report Number
    2023826-2010-01094
    Event Type
    Injury
    Date Received
    November 2, 2010
    Report Date
    October 19, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    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) (STARBURSTS) - (B)(4). EVALUATION METHOD - LENS WORK ORDER SEARCH/MEDICAL REVIEW. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. MEDICAL REVIEW - GLARES AND HALOS MAY BE NOTED BY PATIENTS EVEN IF THEY NEVER HAD ANY OCULAR SURGERY. THIS IS COMMONLY DUE TO ABERRATIONS OR IRREGULARITIES IN THE CORNEA. IT MAY BE NOTED MORE AT LOW LIGHT CONDITIONS WHEN THE PUPIL IS DILATED. IN ICL SURGERY, THE CORNEA IS NOT TOUCHED, THEREFORE PATIENTS WHO HAVE GLARES AND HALOS BEFORE THE SURGERY, WILL COMMONLY RETAIN THESE SYMPTOMS, BUT NO INCREASE IN SEVERITY SHOULD BE EXPERIENCED SINCE THE CORNEA REMAINS UNTOUCHED. THE GLARES AND HALOS HOWEVER, MAY BE PERCEIVED MORE DUE TO THE INCREASED CLARITY OF VISION. FURTHERMORE, THE EFFECTIVE OPTICAL CORNEAL ZONES (EOCZ) OF THE LENSES HAVE A MAXIMUM OF 6.17 TO 7.30 MM DEPENDING ON THE ICL POWERS. THIS IS A DESIGN 3/4 LIMITATION WHICH MAY CREATE SIMILAR SYMPTOMS DUE TO THE INTERFACE OF THE OPTICAL ZONE, AND THE PATIENT'S OPTICAL FIELD OF VISION, WHICH MAY BE NOTED WHEN THE PUPIL SIZE IS GREATER THAN THE EOC. GLARES AND HALOS ARE COMMONLY TEMPORARY, LASTING 1-6 MONTHS, BUT MAY ON VERY RARE OCCASIONS BECOME PERMANENT. 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 THAT THE PATIENT HAD AN MICL 12.1MM IMPLANTABLE COLLAMER LENS IMPLANTED IN THE RIGHT EYE ON (B)(6) 2010. AS PART OF THE POST MARKET STUDY, THE PATIENT REPORTED EXPERIENCING HALOS AND STARBURSTS AT NIGHT. THE DOCTOR'S OFFICE WAS CONTACTED. THE DOCTOR REPORTED THAT THE PATIENT HAS LARGE PUPILS. PATIENT HAD PRK FOR ASTIGMATISM ON (B)(6) 2010. THE ICL REMAINS IMPLANTED. SEE MFR# 2023826-2010-01095 FOR THE LEFT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRDIGE: MODEL UNK, LOT NUMBER UNK| INJECTOR: MODEL UNK, LOT NUMBER UNK| FORM TIP PLUNGER: MODEL UNK, LOT NUMBER UNK