BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4251550 · Received November 14, 2014

    Report

    Report Number
    2023826-2014-00986
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    August 25, 2014
    Report Date
    October 20, 2014
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECES OF FOOT PLATE TORN OFF AND MISSING. UNABLE TO RE-MEASURE LENS. LENS WAS RETURNED DRY. MEDICAL REVIEW: REVIEW OF THE 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, KERATOCONUS, PREGNANT OR NURSING PATIENTS, PATIENTS WITH LOW/ABNORMAL CORNEAL ENDOTHELIAL CELL DENSITY, FUCH'S DYSTROPHY OR OTHER CORNEAL PATHOLOGY, PATIENTS WHO ARE AMBLYOPIC OR BLIND IN THE FELLOW EYE). CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE DEVICE WAS IMPLANTED OFF-LABEL (PATIENT (B)(6)). OFF-LABEL USE OF THE DEVICE, NO CLINICAL DATA CAN SUPPORT THE COMPLAINT EVENT(S) OR THE EFFECT(S) ON THE EFFICACY AND SAFELY 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)(4): EVALUATION:METHOD - WORK ORDER SEARCH.RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.(B)(4): LENS NOT RETURNED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED AN 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN PATIENT'S RIGHT EYE ON (B)(6) 2014. THE LENS WAS EXPLANTED ON (B)(6) 2014 DUE TO ELEVATED IOP (WITHOUT PUPIL BLOCK AND ANGLE CLOSURE). NO OTHER LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737754 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention INJECTOR MODEL AND LOT NUMBER - UNK| FOAM TIP PLUNGER MODEL AND LOT NUMBER - UNK| CARTRIDGE MODEL AND LOT NUMBER - LOT NUMBER - UNK