BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3873168 · Received June 13, 2014

    Report

    Report Number
    2023826-2014-00460
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    February 1, 2014
    Report Date
    May 19, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND TWO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECES OF ONE HAPTIC TORN OFF. 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. 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). CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A PROBABLE ROOT CAUSE OF INADEQUATE VAULTING HAS BEEN DETERMINED TO BE RELATED TO THE INACCURACY OF THE WHITE TO WHITE MEASUREMENT OR A MISMATCH BETWEEN WHITE TO WHITE AND THE SULCUS TO SULCUS DIAMETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). (LENS EXPLANTED). CLAIM # 706558

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2014 DUE TO LOW VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350349 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM115V4 NA

    Patients

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