BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 3223747 · Received July 10, 2013

    Report

    Report Number
    1119421-2013-00750
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS POPPED OUT SUDDENLY AND CAUSED A TEAR IN THE POSTERIOR CAPSULE. THE SURGEON HAS USED THE PRODUCT BEFORE AND FELT SOME RESISTANCE WHILE INJECTING THE LENS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO INDICATED THAT IN ADDITION TO THE POSTERIOR CAPSULE TEAR, ZINN ZONULES WERE "CUT OFF", AND THERE WAS IOL SUBLAXATION. ON POSTOPERATIVE DAY ONE, THE PATIENT PRESENTED WITH CORNEAL EDEMA, INTRAOCULAR PRESSURE (IOP) INCREASE, VITREOUS CLOUDING AND VISUAL ACUITY DECREASE DUE TO THE IOL DISLOCATION. THE PATIENT WAS TREATED WITH MEDICATIONS AND PARACENTESIS WAS PERFORMED TO CONTROL THE IOP. ON POSTOPERATIVE DAY SIX, THE PATIENT WAS TAKEN BACK TO SURGERY TO EXCHANGE THE IOL AND A VITRECTOMY WAS PERFORMED. THE LENS WAS REPLACED WITH A DIFFERENT MODEL LENS WHICH WAS PLACED IN THE CILIARY SULCUS. FOLLOWING THE IOL EXCHANGE, THE LENS WAS CENTERED AND THERE WERE NO ABNORMALITIES NOTED DURING THE EYE EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315045 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD. / HUNTINGTON NA 12208468

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other| R PROVISC VISCOELASTIC| INFINITI VISION SYSTEM