BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4260245 · Received November 18, 2014

    Report

    Report Number
    2023826-2014-00991
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    July 25, 2014
    Report Date
    October 28, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD REVIEW. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING, STERILIZATION OR PACKAGING PROCESSES OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THE LENS WAS RETURNED DRY. THE LENS WAS REHYDRATED IN BSS FOR RE-MEASUREMENT. THE LENS LENGTH WAS MEASURED AND THE RESULT OF THE MEASUREMENT WAS COMPARED AGAINST THE ORIGINAL VALUE AND THE LENS WAS FOUND TO BE IN SPECIFICATION. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    PER 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, FUCHS 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 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. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S.(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).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2014. THE LENS WAS EXPLANTED ON (B)(6) 2014 DUE TO EXCESSIVE VAULTING. SUBSEQUENTLY, THE PATIENT EXPERIENCED ELEVATED INTRAOCULAR PRESSURE AND INFLAMMATION. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746273 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK