BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4103539 · Received September 19, 2014

    Report

    Report Number
    2023826-2014-00747
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 21, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: NO: LENS IMPLANTED. METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND (B)(4) SIMILAR COMPLAINT WAS 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). LENS IMPLANTED.

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: PER MEDICAL REVIEW - ON THE 60-MONTH PATIENT POST-TREATMENT FOLLOW UP FORM FOR ICL, THE PATIENT WROTE THAT SHE "SOMETIMES EXPERIENCED HALOS". NO SECONDARY SURGICALLY OR MEDICALLY INTERVENTIONS WERE PERFORMED OR SCHEDULED. LENS REMAINS IMPLANTED. ACCORDING TO THE DCR, DATED ON 09/02/2014, THE REPORTED SYMPTOMS WERE NOT PRESENT AT THE LAST FOLLOW-UP IN 2009 AND THE VA WAS 20/20 AT THAT TIME. DESPITE MULTIPLE ATTEMPTS NO NEW INFORMATION WAS OBTAINED. IT SHOULD BE NOTED THAT SUBJECTIVE VISUAL DISTURBANCES ("HALOS") 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". THE REASSESSMENT WILL BE PERFORMED WHEN(IF) ADDITIONAL INFORMATION IS OBTAINED FROM THE CURRENT DOCTOR. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE MEDICAL REVIEW, 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 RIGHT EYE (OD). THE PATIENT REPORTED HAS SOMETIMES BEEN EXPERIENCING HALOS. THE ICL WAS IMPLANTED ON (B)(6) 2009 AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584263 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1