BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2840858 · Received November 20, 2012

    Report

    Report Number
    2023826-2012-00931
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    August 27, 2012
    Report Date
    October 23, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - LENS WORK ORDER SEARCH AND MEDICAL REVIEW. RESULTS: THE ICL WAS RETURNED TO STAAR SURGICAL FOR EVALUATION AND THE VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RETURNED IN LIQUID AND THERE WAS NO VISIBLE DAMAGE OBSERVED. A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. THE LENS WAS RE-MEASURED AND COMPARED TO THE ORIGINAL VALUE AND FOUND TO BE WITHIN SPECIFICATIONS. THEREFORE, IT CAN BE JUSTIFIED THAT THE COMPLAINT WAS NOT PRODUCT RELATED. THE MEDICAL REVIEW OF THIS FILE INDICATES THAT THE LENS WAS NOT IMPLANTED IN ACCORDANCE WITH THE DFU REQUIREMENTS (E.G. PATIENT AGE BELOW 21 OR OVER 45 YEARS, ACD BELOW 2.8MM FOR ICL/TICL AND BELOW 3.0MM FOR VICL/VTICL, KERATONOCONNUS, PREGNANT OR NURSING PATIENTS, PATIENT WITH LOW/ABNORMAL CORNEAL ENDOTHELIAL CELL DENSITY, FUCH'S DYSTROPHY OR OTHER CORNEAL PATHOLOGY, PATIENTS WHO ARE AMBLYOPIC OR BLIND IN THE FELLOW EYE). OFF-LABEL USE OF THE DEVICE, NO CLINICAL DATA CAN SUPPORT THE COMPLAINT EVENTS(S) OR THE EFFECT(S) ON THE EFFICACY AND SAFETY OF THE DEVICE. THIS INFORMATION HAS BEEN COMMUNICATED TO THE MEDICAL ADVISOR OF STAAR SURGICAL AND TO THE SURGEON IN CASE OF SEVERE DETERIORATION OF PATIENT HEALTH. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6)

    Description of Event or Problem · 1

    THE SURGEON INSERTED THE ICM130V4 13.0 MM IMPLANTABLE COLLAMER IN THE LEFT (OS) EYE ON (B)(6) 2012 AND A REFRACTIVE SURPRISE WAS OBSERVED ON (B)(6) 2012. THE LENS WAS REMOVED AND REPLACED WITH A LOWER POWER LENS. TWO DAY FOLLOWING THE LENS REPLACEMENT, THE WOUND WAS SUTURED AS IRREGULAR WOUND WAS CAUSING ASTIGMATISM. DURING THE PATIENT'S LAST OFFICE VISIT ON (B)(6) 2012 THE BCVA WAS 20/25 AND UCVA 20/30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM130V4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention