BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2871022 · Received December 12, 2012

    Report

    Report Number
    2023826-2012-00980
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    June 2, 2012
    Report Date
    November 14, 2012
    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 - LENS WORK ORDER SEARCH. MEDICAL REVIEW. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RETURNED DRY AND THERE WAS NO VISIBLE DAMAGE OBSERVED. A LENS WORK ORDER SEARCH WAS PERFORMED AND REVEALED THAT THERE WAS NO SIMILAR COMPLAINT FOR THE SAME TYPE OF PROBLEM FROM THIS WORK ORDER. MEDICAL REVIEW - 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 AND LENGTH OF CILIARY SULCUS IN AN INDIVIDUAL CASE; IRREGULAR CILIARY SULCUS OR CILIARY SULCUS CYST). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN ICM125V4 IMPLANTABLE COLLAMER LENS IN THE LEFT (OS) EYE ON (B)(6) 2012, AND LOW VAULT WAS NOTED ON (B)(6) 2012. THE LENS WAS REMOVED ON (B)(6) 2012 AND REPLACED WITH A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM125V4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention