BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2904868 · Received January 9, 2013

    Report

    Report Number
    2023826-2013-00033
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    August 31, 2012
    Report Date
    December 10, 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). SECONDARY SURGERY. EXPLANT. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RETURNED DRY WITH A TORN HAPTIC AND A CLEAR SURGICAL RESIDUE ON THE LENS. A LENS WORK ORDER SEARCH REVEALED THAT THERE WERE 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 LENGTH OF CILIARY SULCUS IN AN INDIVIDUAL CASE; IRREGULAR CILIARY SULCUS OR CILIARY SULCUS CYST). A HIGHER THAN IDEAL VAULTING IN THE ABSENCE OF SIGN AND/OR SYMPTOMS DOES NOT NEED AN EXCHANGE. HOWEVER, THE SURGEON MAY DECIDE TO EXCHANGE IF HE 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 THE ICM125V4 12.5MM IMPLANTABLE COLLAMER LENS ON (B)(6) 2012 AND EXCESSIVE VAULT WAS NOTED THE NEXT DAY. THE LENS WAS REMOVED ON (B)(6) 2012 AND REPLACED WITH A SHORTER LENGTH LENS AND THIS RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10622 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM125V4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention