BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN TICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3911170 · Received July 2, 2014

    Report

    Report Number
    2023826-2014-00508
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 4, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S BUT NOT MARKETED IN THE U.S. DATE OF BIRTH - UNK. (B)(4) - VISION, LOSS OF; UNINTENDED MOVEMENT. 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 REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). LENS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: MEDICAL REVIEW - 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). SEVERAL FACTORS MAY CONTRIBUTE TO ROTATION OF AN ICL (I.E. PATIENTS ANATOMICAL STRUCTURE, A SHORT LENS, HAPTIC POSITION, ETC.). CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE LENS WAS EXPLANTED ON (B)(6) 2014. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY WAS 20/25.

    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 (OS) ON (B)(6) 2014. THE LENS HAD A 90º ROTATION NOT ASSOCIATED TO A LOW VAULT., WITH A LOSS OF BEST-CORRECTED VISUAL ACUITY - 20/400 (PRE-OP - 20/50). THE ICL REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385861 VISIAN TICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VTICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK