BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2833688 · Received November 15, 2012

    Report

    Report Number
    2023826-2012-00909
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    July 20, 2012
    Report Date
    October 19, 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 LENS SHOWED THE LENS WAS RETURNED DRY, THERE WAS A CLEAR SURGICAL RESIDUE ON THE DEVICE, HOWEVER, THERE WAS NO VISIBLE DAMAGE OBSERVED. THE LENS WAS RE-MEASURED AND FOUND TO BE WITHIN THE ORIGINAL DESIGN SPECIFICATIONS. THEREFORE, IT CAN BE JUSTIFIED THAT THE COMPLAINT IS NOT PRODUCT RELATED. A LENS WORK ORDER SEARCH REVEALED THERE WERE NO SIMILAR COMPLAINTS FOUND WITHIN THE WORK ORDER. ACCORDING TO (B)(4) 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). SEVERAL CONDITIONS MAY ARISE FROM THIS EVENT (I.E. PUPILLARY BLOCK, MALIGNANT GLAUCOMA, INCREASED IOP, ECT.). SEVERAL CONDITIONS MAY ARISE FROM THIS EVENT (IE 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN ICM115V4 11.5MM IMPLANTABLE COLLAMER LENS ON (B)(6) 2012 AND ELEVATED INTRAOCULAR PRESSURE ASSOCIATED WITH EXCESSIVE VAULT WAS NOTED THE NEXT DAY. THE LENS WAS REMOVED ON (B)(6) 2012 AND WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM115V4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention