BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2983577 · Received February 28, 2013

    Report

    Report Number
    2023826-2013-00169
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    October 24, 2012
    Report Date
    February 7, 2013
    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 ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. 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. MEDICAL REVIEW - CLINICAL STUDIES HAVE SHOWN THAT ANTERIOR SUBCAPSULAR CATARACT OCCURS IN 1.3% OF PATIENTS WHERE AN ICL HAS BEEN IMPLANTED, FOLLOWING THE RECOMMENDATIONS FOR USE. THIS USUALLY OCCURS WITHIN THE 1ST 6 MONTHS POST-OP. THE MOST PROBABLE CAUSE HAS BEEN DETERMINED TO BE CRYSTALLINE LENS TOUCH DURING SURGERY WHICH COULD HAVE BEEN EITHER FROM THE INSTRUMENTS USED OR THE ICL ITSELF. 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 SULCUS OR CILIARY SULCUS CYST, ETC). STAAR RECOMMENDS THE ICL TO BE LEFT IMPLANTED IF NO CATARACTS ARE NOTED OR IN CASES WHERE THERE IS A TRACE ANTERIOR SUBCAPSULAR CATARACT WITH NO PROGRESSION. STAAR BELIEVES THAT THE ACTION TO REMOVE AND/OR REPLACE THE ICL INCREASES THE RISK FOR ANTERIOR SUBCAPSULAR CATARACT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE 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).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2012 DUE TO LOW VAULTING. AN ANTERIOR SUBCAPSULAR OPACITY WAS OBSERVED ON (B)(6) 2012. THE LENS WAS EXCHANGED FOR A LONGER LENS WHICH RESOLVED THE PROBLEM. THE PATIENT'S BCVA WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88239 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM115V4 NA

    Patients

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