BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2870962 · Received December 12, 2012

    Report

    Report Number
    2023826-2012-00978
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    April 12, 2012
    Report Date
    May 31, 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

    (B)(4).

    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 A HAPTIC WAS TORN. 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).SEVERAL CONDITIONS MAY ARISE FROM THIS EVENT (I.E. PUPILLARY BLOCK, MALIGNANT GLAUCOMA, INCREASED IOP, ECT.). TO PREVENT ANY OF THESE COMPLICATIONS FROM OCCURRING, STAAR RECOMMENDS THAT THE LENS BE EXPLANTED AND/OR EXCHANGED WITH THE RIGHT SIZE ONCE THE SURGEON DETERMINES THAT THIS CONDITION MAY AFFECT THE OUTCOME OF THE PATIENT'S VISION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN ICM125V4 IMPLANTABLE COLLAMER LENS ON (B)(6) 2012 AND ELEVATED IOP ASSOCIATED WITH EXCESSIVE VAULT WAS NOTED ON (B)(6) 2012. THE LENS WAS REMOVED ON (B)(6) 2012 AND REPLACED WITH A SHORTER 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 28 YR Required Intervention