BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4555256 · Received February 27, 2015

    Report

    Report Number
    2023826-2015-00210
    Event Type
    Injury
    Date Received
    February 27, 2015
    Date of Event
    April 20, 2010
    Report Date
    February 3, 2015
    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

    PT WEIGHT: UNK. EVENT DATE: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS DRY WITH NO VISIBLE DAMAGE. THE LENS WAS RE-HYDRATED AND BOTH THE LENGTH AND WIDTH WERE REMEASURE AND DETERMINED TO BE WITHIN ORIGINAL DESIGN SPECIFICATIONS. A LENS WORK ORDER SEARCH REVEALED THERE WERE NO SIMILAR COMPLAINTS FOUND WITHIN THE WORKORDER. MEDICAL REVIEW: EXPECTED SEQ WAS -024D IN THE RIGHT EYE AND TO -2.12 D IN THE LEFT AND ACHIEVED WAS -1.37 D IN RIGHT EYE AND -0.75 D IN THE LEFT EYE. UCVA IN BOTH EYES REMAINED OPTIMAL. HOWEVER, FIVE YEARS POSTOPERATIVELY, THE SEQ INCREASED TO -2.50 D IN RIGHT EYE AND TO -2.12 D IN THE LEFT EYE AND UCVA DECREASED. THE ICL VAULT REMAINED STABLE (160UM IN RIGHT AND 69UM IN THE LEFT EYE). NINE YEARS POSTOPERATIVELY, THE SURGEON DECIDED TO EXCHANGE BOTH LENSES FOR A LONGER ONE WITH DIFFERENT POWER (-20.50 D/-18.50 D) TO ADJUST FOR THE ERROR. THIS RESOLVED THE PROBLEM. VISION IS OPTIMAL IN BOTH EYES (UCVA =20/20 RIGHT AND 20/24 IN LEFT EYE. THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS LOW VAULT SECONDARY TO A SHORT LENS AND CHANGE OF REFRACTION OVERTIME DUE TO PROGRESSION OF MYOPIA. ACCORDING TO USE FMEA (FAILURE MODES AND EFFECT ANALYSIS) IT HAS BEEN DETERMINED THAT THE INADEQUATE VAULT IS A CONSEQUENCE OF WRONG LENS USE FAILURE MODE (I.E. IMPROPER WHITE TO WHITE MEASUREMENTS, 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). CONCLUSION: BASED ON THE COMPLAINT INFORMATION, WORK ORDER SEARCH AND EVALUATION OF THE RETURNED PRODUCT, A PROBABLE ROOT CAUSE OF THE INADEQUATE VAULTING HAS BEEN DETERMINED TO BE RELATED TO INACCURACY OF THE WHITE TO WHITE MEASUREMENT OR 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 LEFT EYE (OS) ON (B)(6) 2005 AND 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. SEE MFR REPORT# 2023826-2015-00209 FOR THE OTHER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139996 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK