BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2473810 · Received February 22, 2012

    Report

    Report Number
    2023826-2012-00134
    Event Type
    Injury
    Date Received
    February 22, 2012
    Date of Event
    February 7, 2012
    Report Date
    January 24, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: LENS WORK ORDER SEARCH MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE ICL EXHIBITED A HIGH VAULT IN THIS PATIENT. 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 PATIENT'S VISION. CONCLUSIONS - (NO DEVICE FAILURE): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW, IT WAS DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR THE EVENT WAS INACCURATE WHITE TO WHITE MEASUREMENTS AS THE RESULT OF DIFFICULTY IN CLINICAL SIZING. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A MICL 13.2MM IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE. THE LENS WAS REMOVED DUE TO HIGH VAULTING AND ANTERIOR CHAMBER SHALLOWING. NO PROBLEM WITH PATIENT'S PRESSURE. THE SURGEON USED THE SAME INCISION TO REMOVE THE LENS AND NO SUTURE WAS USED. THE LENS WAS EXCHANGED FOR A SAME MODEL, SAME POWER BUT SMALLER DIAMETER LENS. REPORTER STATED NO LENS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention CARTRIDGE: MODEL AND LOT NUMBER - UNK| INJECTOR: MODEL AND LOT NUMBER - UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER - UNK