BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4201196 · Received October 27, 2014

    Report

    Report Number
    2023826-2014-00800
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    June 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 PIECE OF ONE HAPTIC TORN OFF AND MISSING. LENS WAS RETURNED DRY. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE ON THE PRODUCT. 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). ACCORDING TO USE FMEA (FAILURE MODES AND EFFECT ANALYSIS) IT HAS BEEN DETERMINED THAT INADEQUATE VAULTING IS A CONSEQUENCE OF A WRONG LENS USE FAILURE MODE (I.E. IMPROPER WHITE TO WHITE MEASUREMENT, VARIABILITY OF THE WHITE TO WHITE MEASUREMENTS BASED UPON DIFFERENT TECHNIQUES UTILIZED, IMPROPER SULCUS TO SULCUS MEASUREMENT (IF UBM USED), AND PATIENT CONDITION; POOR CORRELATION OF WHITE TO WHITE MEASUREMENT AND LENGTH OF CILIARY SULCUS IN AN INDIVIDUAL CASE; IRREGULAR CILIARY SULCUS OR CILIARY SULCUS CYST). 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 (ACD BELOW 3.0MM); NO CLINICAL DATA CAN SUPPORT THE COMPLAINT EVENT OR THE EFFECT 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).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED AN 12.1MM VICMO12.1 IMPLANTABLE COLLAMER LENS IN PATIENT'S RIGHT EYE. THE LENS WAS EXPLANTED DUE TO LOW VAULT. THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM. THE STATUS OF EYE IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682640 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER - UNK| INJECTOR MODEL AND LOT NUMBER - UNK