BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2051245 · Received April 6, 2011

    Report

    Report Number
    2023826-2011-00277
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 8, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: LENS WORK ORDER SEARCH. MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME ORDER. MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE ICL EXHIBITED A HIGH VAULT IN THIS PT WITH NARROWING OF THE ANGLE. THE ICL REMAINS IMPLANTED BUT THE PT WILL BE MONITORED CLOSELY. 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. SINCE THIS PT HAS NYSTAGMUS, IT WOULD BE EXTREMELY DIFFICULT TO MEASURE WTW ACCURATELY. SURGEONS ARE ADVISED TO MEASURE WHITE-TO-WHITE UNDER THE MICROSCOPE WITH A CALIPER, AND CONFIRM THIS WITH A STEEL RULER. CALIPERS MAY BE BENT, AND COULD GIVE A WRONG READING. 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 AND/OR EXCHANGED WITH THE RIGHT SIZE 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 13.2MM IMPLANTABLE COLLAMER LENS IN PT'S RIGHT EYE ON (B)(6) 2010. THE LENS IS SCHEDULED TO BE REMOVED DUE TO EXCESSIVE VAULTING AND NARROW ANGLE CLOSURE. THE LENS REMAINS IMPLANTED BUT THE PT WILL BE MONITORED CLOSELY. REPORTER STATED THE CAUSE OF THIS INCIDENT IS DUE TO WHITE TO WHITE MEASUREMENT NOT MATCHING. THE PT HAS UNUSUAL EYES AND ROTATION NYSTAGMUS. SEE MFR #2023826-2011-00184 FOR THE LEFT EYE.

    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 Required Intervention CARTRIDGE: MODEL - SFC-45 FP - LOT NUMBER UNK| INJECTOR: MODEL - MSI-PF - LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL - LOT NUMBER UNK