BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3911190 · Received July 2, 2014

    Report

    Report Number
    2023826-2014-00501
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    November 16, 2013
    Report Date
    June 4, 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

    (B)(4) - CATARACT, INDUCED; (LENS EXPLANTED). (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 A PIECE 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 SULCUS OR CILIARY SULCUS CYST, ETC). 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. 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 SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (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) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2014 DUE TO AN ANTERIOR SUBCAPSULAR OPACITY, WHICH WAS NOTED ON (B)(6) 2013. THE LENS WAS EXCHANGED FOR A LONGER LENS WHICH RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386163 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK