BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2000362 · Received February 18, 2011

    Report

    Report Number
    1119421-2011-00127
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 20, 2011
    Manufacturer
    ALCON RESEARCH LTD/ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: NO LOT/SERIAL OR SAMPLE WAS RETURNED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. CANUT JORDANA M, FORMIGO D, GONZALEZ, R, REUS J. (2010). PIGMENT DISPERSION SYNDROME ASSOCIATED WITH INTRAOCULAR LENS IMPLANTATION: A NEW SURGICAL TECHNIQUE. CLINICAL OPHTHALMOLOGY 2010: 4 1263-1266. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, A SURGEON REPORTED A PT WHO PRESENTED TO THE EMERGENCY ROOM DUE TO BLURRED VISION AFTER TRAUMA. A COMPETITOR'S INTRAOCULAR LENS (IOL) WAS FOUND TO BE SLIGHTLY DISPLACED NASALLY WITH MARKED IRIDOPSEUDOPHAKODONESIS, TYNDALL POSITIVE, +3 FLARE, AND PIGMENT DEPOSITS AT 5 TO 7 HOURS. INTRAOCULAR PRESSURE (IOP) WAS 26 MMHG. THE PT'S VISUAL ACUITY WAS NOTED TO BE APPROX 20/30. THE PT WAS TREATED WITH MEDICATIONS FOR TWO WEEKS. ONE MONTH LATER, THE IOP WAS NORMAL AND TYNDALL WAS NEGATIVE. TWO MONTHS LATER, THE PT PRESENTED TO THE EMERGENCY ROOM AGAIN AND THE COMPETITOR'S IOL WAS NOTED TO BE IN THE VITREOUS. THE PT WAS TAKEN TO SURGERY WHERE AN ANTERIOR VITRECTOMY WAS PERFORMED WITH AN IOL EXCHANGE. THE SURGEON IMPLANTED THIS MFR'S IOL DURING THIS PROCEDURE WITH A SCLERAL SUTURE. IMMEDIATELY FOLLOWING THE PROCEDURE, THE IOL WAS NOTED TO BE IN POSITION AND THE IOP WAS NORMAL. AT ONE AND THREE MONTHS POST-EXCHANGE, THE PT PRESENTED WITH TWO EPISODES OF INTRAOCULAR HYPERTENSION. EXAMINATION SHOWED WIDE CHAMBER WITH PIGMENT DISPERSION IN THE ANTERIOR CHAMBER AND A CORNEA WITH SOME OLD ENDOTHELIAL PIGMENT. IOP'S OF 30 AND 50 MMHG RESPECTIVELY WERE TREATED WITH MEDICATIONS. AT SIX MONTHS POST-EXCHANGE, THE PT REPORTED BLURRED VISION. ABUNDANT PIGMENT DISPERSION WAS NOTED IN THE ANTERIOR CHAMBER, MARKED IRIS CONCAVITY AND AN UNTREATED IOP OF 14 MMHG. AN OPTICAL COHERENCE TOMOGRAPHY (OCT) OF THE ANTERIOR SEGMENT SHOWED IRIS CONCAVITY PRODUCED BY CONTACT BETWEEN THE POSTERIOR FACE OF THE IRIS AND THE ANTERIOR FACE OF THE IOL. A YAG LASER IRIDOTOMY WAS PERFORMED AND RECTIFIED THE IRIS CONCAVITY. AT SUCCESSIVE CHECK-UPS, GOOD IRIDOLENTICULAR SEPARATION WAS NOTED, PERMEABLE IRIDOTOMIES, ANTERIOR CHAMBER WITHOUT CELLULARITY, AND IOP OF 10 MMHG. TWO MONTHS FOLLOWING THE YAG IRIDECTOMY, THE PT REPORTED A NEW EPISODE OF BLURRED VISION. EXAMINATION SHOWED EXTENSIVE PIGMENT DISPERSION IN THE ANTERIOR CHAMBER. THE IOP WAS NOTED TO BE NORMAL. AFTER TWO MONTHS OF MEDICAL TREATMENT WITHOUT CLINICAL IMPROVEMENT, A 360 DEGREE IRIDOPLASTY OF THE PERIPHERAL IRIS WAS PERFORMED WHICH ACHIEVED GOOD ANATOMIC RESOLUTION BUT REQUIRED TREATMENT WITH MEDICATIONS TO CONSERVE GOOD VISUAL ACUITY. THE IRIS HAD A POOR CONTRACTILITY RESPONSE NOTED EVEN WITH MEDICATION. TWELVE MONTHS FOLLOWING THE IRIDOPLASTY, THE PT HAD NEW EPISODES OF BLURRED VISION CAUSED BY DISPERSION OF PIGMENT IN THE ANTERIOR CHAMBER WHICH RESOLVED FOLLOWING TREATMENT WITH MEDICATIONS. AN OCT OF THE ANTERIOR SEGMENT SHOWED IRIDOLENTICULAR CONTACT. THE PT REFUSED TO HAVE THE IOL REMOVED OR REPOSITIONED TO THE ANTERIOR CHAMBER, SO PROLENE SUTURES WERE PLACED ON THE IRIS SURFACE TO PERMANENTLY REMOVE THE IRIDOLENTICULAR CONTACT. SIX MONTHS FOLLOWING THE SUTURE PLACEMENT, THERE WAS GOOD TOLERANCE, AN ABSENCE OF PIGMENT DISPERSION IN THE ANTERIOR CHAMBER. AN OCT SHOWED GOOD IRIDOLENTICULAR SEPARATION. THE PT'S VISUAL ACUITY WAS NOTED TO BE APPROX 20/30 WITH NORMAL IOP. IN A F/U, THE SURGEON REPORTED THAT PT WAS HOSPITALIZED FOR TWO DAYS. THE EVENT RESOLVED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD/ HUNTINGTON MA60MA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R HEALON