BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4200418 · Received October 24, 2014

    Report

    Report Number
    2023826-2014-00865
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    February 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 COMPLAINTS 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 SUB-CAPSULAR CATARACT OCCURS IN 1.3% OF PATIENTS WHERE AN ICL HAS BEEN IMPLANTED, FOLLOWING THE RECOMMENDATIONS FOR USE. THIS USUALLY OCCURS WITHIN THE 1S 6 MONTHS POST-OP. THE MOST PROBABLE CAUSE HAS BEEN DETERMINED TO BE CRYSTALLINE LENS TOUCH DURING SURGERY WHICH COULD HAVE BEEN EITHER FORM THE INSTRUMENT USED OR THE ICL ITSELF. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A PROBABLE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE LENS TOUCH DURING SURGERY. THERE IS NOT ENOUGH CLINICAL DATA TO DETERMINE THE EXACT CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE 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 - 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). 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, 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).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2014. THE LENS WAS EXPLANTED ON (B)(6) 2014 DUE TO LOW VAULTING. THE ICL WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS NOT RESOLVED. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678361 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK