BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN TICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4200990 · Received October 27, 2014

    Report

    Report Number
    2023826-2014-00798
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 26, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S BUT NOT MARKETED IN THE U.S. PT WEIGHT: UNK. (B)(4). METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSION: CONCLUSION NOT YET AVAILABLE. EVALUATION IS IN PROGRESS. . (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND SMALL PIECES OF HAPTIC AND OPTIC TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. 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). 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. 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)). (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE. THE ICL WAS IMPLANTED UPSIDE DOWN AND WAS EXPLANTED AND EXCHANGED FOR SAME MODEL AND SIZE. THIS RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683272 VISIAN TICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VTICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention INJECTOR MODEL AND LOT NUMBER - UNK| CARTRIDGE MODEL AND LOT NUMBER - UNK