BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2496254 · Received March 14, 2012

    Report

    Report Number
    2023826-2012-00199
    Event Type
    Injury
    Date Received
    March 14, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 15, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD - LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULT - A WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE ICL EXHIBITED A HIGH VAULT IN THIS PT WHICH LED TO INCREASED IOP AND NARROWING OF THE ANGLE. THE ICL WAS EXCHANGED WITH A SHORTER LENS WHICH RESOLVED THE PROBLEM. THE ROOT CAUSE OF EXCESSIVE VAULTING HAS BEEN DETERMINED TO BE RELATED TO THE INACCURACY OF THE WHITE TO WHITE MEASUREMENT OR A MISMATCH BETWEEN WHITE TO WHITE AND THE SULCUS TO SULCUS DIAMETER. SEVERAL CONDITIONS MAY ARISE FROM THIS EVENT (I.E. PUPILLARY BLOCK, MALIGNANT GLAUCOMA, INCREASED IOP ETC.) TO PREVENT ANY OF THESE COMPLICATIONS FROM OCCURRING, STAAR RECOMMENDS THAT THE LENS BE EXPLANTED ONCE THE SURGEON DETERMINES THAT THIS CONDITION MAY AFFECT OUTCOME OF THE PT'S VISION. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A MICL 13.7MM IMPLANTABLE COLLAMER LENS IN THE PT'S RIGHT EYE. THE ICL WAS REMOVED DUE TO EXCESSIVE VAULTING, INCREASED EYE PRESSURE, NARROWING OF THE ANGLES, ANGLE CLOSURE AND SHALLOWING OF THE ACD. THE DOCTOR STATED THE PT HAD MUSCLE SURGERY AS A CHILD AND IT HAD CONSTRICTED/CLOSED THE ANTERIOR CHAMBER. THE ICL WAS TOO LONG. LENS WAS EXCHANGED FOR A SMALLER LENGTH LENS. PT IS DOING VERY WELL. THIS EVENT WAS DUE TO PT'S CONDITION AND WAS NOT LENS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL13.7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention INJECTOR SYSTEM MODEL - NAVIJECT, LOT # UNK