BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2831703 · Received November 9, 2012

    Report

    Report Number
    2023826-2012-00892
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 19, 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
    GA, US
    Reporter Occupation
    NURSE

    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 AFTER THE SECOND ICL WAS IMPLANTED, PUPILLARY BLOCK OCCURRED WHERE IRIS SWEEPING AND ENLARGEMENT OF PI WAS PERFORMED 1 DAY POST OP. PUPILLARY BLOCK OCCURS WHEN AQUEOUS FLOW FROM THE POSTERIOR CHAMBER TO THE ANTERIOR CHAMBER IS INTERRUPTED BY THE APPOSITION OF THE PUPILLARY MARGIN WITH ADJACENT STRUCTURES. WHEN THE LENS OPTIC OF THE ICL ADHERES TO THE PUPILLARY MARGIN, ACCUMULATION OF AQUEOUS IN THE POSTERIOR CHAMBER OCCURS, LEADING TO INTRAOCULAR PRESSURE (IOP) RISE. IMPLANTATION OF THE ICL REQUIRES THAT IRIDOTOMIES BE PERFORMED 2 WEEKS PRIOR TO IMPLANTATION OF THE MICL TO PREVENT PUPILLARY BLOCK. FIBRINOUS INFLAMMATORY MATERIALS GENERATED DURING ANY INTRAOCULAR SURGERY MAY CAUSE INTRAOCULAR INFLAMMATORY REACTION LEADING TO OCCLUSION OF THE IRIDOTOMY WHICH WOULD REQUIRE ENLARGEMENT TO VERIFY PATENCY OF THE IRIDOTOMY. A SUTURE WAS PLACED AT THE END OF THE PROCEDURE TO SECURE THE INCISION. CORNEAL SUTURING MAY CAUSE INDUCED ASTIGMATISM, HOWEVER IT IS DEPENDENT ON THE TIGHTNESS OF THE SUTURE. IN THIS CASE, SUTURE WAS ONLY PLACED TO SECURE THE WOUND AND WOULD NOT CREATE ANY SERIOUS INJURY. (B)(4).

    Description of Event or Problem · 1

    THE REPORTED STATED THE SURGEON IMPLANTED INITIAL MICL13.2MM -10.5 DIOPTER IMPLANTABLE COLLAMER LENS IN PATIENT¿S RIGHT EYE ON (B)(6) 2012. THE ICL WAS REMOVED ON (B)(6) 2012 DUE TO LENS OVERCORRECTED. ICL WAS EXCHANGED FOR A SECOND ICL, A MICL13.2 -9.0. THE PT DEVELOPED INCREASED IOP RELATED TO PUPILLARY BLOCK ONE DAY AFTER SURGERY. THE PT RETURNED TO THE OPERATING ROOM ON (B)(6) 2012. THE IRIS WAS SWEPT, FREEING THE PI. THE PI WAS THEN ENLARGED AND SUTURE ADDED. PT HAS HAD NORMAL IOP SINCE THAT TIME AND IS BEING MONITORED CLOSELY. PT¿S MEDICAL HISTORY INCLUDED HYPERTENSION BUT NO OCULAR CONDITIONS. SEE MFR NUMBER: 2023826-2012-00893 FOR INITIAL ICL.

    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 56 YR Required Intervention CARTRIDGE: MODEL SFC-45 FP, LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNK| INJECTOR: MODEL AND LOT NUMBER UNKNOWN