BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 2051216 · Received April 6, 2011

    Report

    Report Number
    1119421-2011-00374
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 7, 2011
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE LENS AND THE DEVICE WERE RETURNED FOR EVALUATION. SOLUTION IS DRIED ON THE LENS. LENS DAMAGE WAS OBSERVED TO THE OPTIC. THE DEVICE WAS RETURNED AND NO DAMAGE WAS OBSERVED. THE PLUNGER IS FULLY ADVANCED. THE OBSERVED SOLUTION DOES NOT APPEAR TO BE AN APPROVED VISCOELASTIC. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE DETERMINED BY THE PRODUCT EVALUATION. HOWEVER, DUE TO INFORMATION PROVIDED, THE EVENT MAY HAVE OCCURRED DUE TO A FAILURE TO FOLLOW THE DFU. THE CUSTOMER USED AN UNAPPROVED VISCOELASTIC IN THE DEVICE. VISCOSITY OF AN UNAPPROVED OVD MAY CONTRIBUTE TO UNDERFILL/OVERFILL, MISFOLDING OF THE TRAILING HAPTIC, LACK OF LUBRICITY OR OTHER UNPREDICTABLE OUTCOMES. 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SUPPLY OFFICER REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, DURING THE FINAL PHASE THE IOL SHOT OUT AND THROUGH THE POSTERIOR CAPSULE (PC) WITH VITREOUS LOSS. THE SURGEON REPORTED THE PATIENT WAS FOR SECOND EYE SURGERY WITH EXTREMELY DENSE CATARACT. THE SENIOR SURGEON DID HIS FIRST EYE WHICH WAS DIFFICULT WITH AN EXCELLENT RESULT. THIS REPORT IS FOR THE SECOND EYE. THE SENIOR SURGEON SUPERVISED A TRAINEE TO DO THE SECOND EYE TO EXPAND HIS EXPERIENCE. THE SURGERY WENT WELL AND WAS UNCOMPLICATED. THE BAG WAS FILLED FULLY WITH VISCOELASTIC AND THE NURSE WHO HAS BEEN TRAINED IN THE LENS INJECTOR SYSTEM FILLED THE INJECTOR APPROPRIATELY. THE SURGEON SLOWLY INJECTED THE LENS. NINETY PERCENT OF THE LENS HAD EXITED THE TIP WITHOUT A PROBLEM. THE INJECTOR THEN STALLED A LITTLE AND WITH THE LENS PROGRESS STALLED, THE SURGEON APPLIED A SMALL INCREASE IN PRESSURE COMMENSURATE WITH ANY INJECTOR AND THE LENS SHOT OUT. THE LENS WENT THROUGH THE PC WITH EXTENSIVE VITREOUS LOSS AND HALF THE LENS IN THE POSTERIOR CHAMBER. THE SENIOR SURGEON TOOK OVER AND EXPLANTED THE LENS CAREFULLY. AN ANTERIOR VITRECTOMY WAS PERFORMED WITH A SULCUS IOL PLACED. SUTURES WERE REQUIRED. THE TRAINEE HAS USED THE INJECTOR ON AROUND 20 PATIENTS APPROPRIATELY. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE SURGICAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH LTD/HUNTINGTON NA 11033276

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SYRINGE| PROVISC USED IN THE EYE.| HPMC WAS USED TO FILL THE DELIVERY SYSTEM