BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON DUET

    MDR report key: 3093013 · Received May 3, 2013

    Report

    Report Number
    2020664-2013-00026
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER UM30116 (HEALON DUET). THE MANUFACTURING RECORD REVIEW FOUND THAT ALL RESULTS WERE WITHIN SPECIFICATION. HEALON DUET LOT #UM30116 CONTAINS HEALON LOT #UK30867 AND HEALON ENDOCOAT LOT #024687. THERE WERE NO NONCONFORMITIES ASSOCIATED WITH LOT #UK30867. ALL FINISHED PRODUCT TESTING AND MICRO TESTING WAS CONFIRMED TO BE ACCEPTABLE. BATCH RELATED AIR SAMPLING AND SURFACE SAMPLING ON ASEPTIC PACKAGING WAS CONFIRMED ACCEPTABLE. HEALON ENDOCOAT LOT #024687: A REVIEW OF THE MANUFACTURING BATCH RECORD, REVIEW OF COMPLAINT HISTORY, PRODUCT ARCHIVE TESTING TO CONFIRM SPECIFICATION ADHERENCE, (STERILITY, PARTICULATES, PH, ENDOTOXIN, AND OSMOLALITY) WAS CONDUCTED. THE ROOT CAUSE FOR THE REPORTED ISSUE WAS NOT LIKELY RELATED TO THE MANUFACTURING PROCESS. THE RECORD REVIEW AND ARCHIVE TEST DATA CONFIRMED THE PRODUCT MET SPECIFICATIONS. THE BATCH RECORD REVIEW/ARCHIVE TESTING NOTED THERE WERE NO PROCESSING DEVIATIONS THAT WOULD INDICATE ANY ISSUES RELATING TO SOLUTION STERILITY, PARTICULATES, PH, ENDOTOXIN, OR OSMOLALITY. STERILITY, PARTICULATES, PH, ENDOTOXIN, AND OSMOLALITY TESTING IS CONDUCTED ON THE BULK PRE-FILLED SOLUTION, THE FILLED SYRINGES (BEGINNING, MIDDLE, AND THE END OF THE FILL) AND THE FINAL PRODUCT PRIOR TO RELEASE. ADDITIONAL CONFIRMATION TESTING WAS PERFORMED ON PRODUCT ARCHIVE SAMPLES. BOTH BATCH TESTING REVIEW AND ARCHIVE CONFIRMATION TESTING CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO ROOT CAUSE COULD BE DETERMINED. THE INVESTIGATION SHOWED THAT THE PRODUCT STERILITY, PARTICULATES, PH, ENDOTOXIN, AND OSMOLALITY WERE ACCEPTABLE THROUGH THE PRODUCTION PROCESS, RELEASE TESTING, AND CONFIRMATION TESTING OF THE ARCHIVE PRODUCT. NO ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD BE IDENTIFIED BASED ON THE REVIEW OF THE BATCH RECORDS AND CONFIRMATION TESTING OF THE ARCHIVE TESTING. RETAIN SAMPLE TESTING INCLUDED A VISUAL INSPECTION WHERE NO VISIBLE DEFECTS WERE FOUND ON THE PACKAGE FOR HEALON DUET LOT #UM30116, NO VISIBLE DEFECTS WERE FOUND ON THE PACKAGE, CANNULA OR SOLUTION ON HEALON LOT #UK30867. BACTERIAL ENDOTOXINS TEST WERE PERFORMED ON RETAINED SAMPLE LOT #UK30867 AND RESULTS WERE WITHIN SPECIFICATION. A ROOT CAUSE FOR THE REPORTED COMPLAINT WAS NOT FOUND AS RESULTS WERE WITHIN SPECIFICATION. RETAIN SAMPLING VISUAL INSPECTION OF LOT #024687 SHOWED THAT THE SYRINGES WERE FREE OF PARTICULATES AND CLOUDINESS. NO OTHER DEFECTS WERE NOTED DURING INSPECTION. ALL ARCHIVE SYRINGES MET REQUIREMENTS. BOTH ADVERSE EVENT AND PRODUCT PROBLEM. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DISPERSIVE CONTAINED IN THE HEALON DUET: MODEL: VT585, LOT NUMBER: 024687, MANUFACTURE DATE: 11/05/2012, EXPIRATION DATE: 10/31/2014. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT POSSIBLY ACQUIRED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AFTER THE USE OF BALANCED SALT SOLUTION (BSS) AND A HEALON DUET. PATIENT PRESENTED FOUR (4) DAYS POST-OPERATIVELY WITH SYMPTOMS OF FOGGINESS, DARK FLOATERS, SEVERE DECREASE IN VISION WITH 3-4 (+) AC CELLS AND HYPOPYON. IN ADDITION, IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE A VITREOUS TAP AND INSTEAD WAS PRESCRIBED TOPICAL STEROIDS. PATIENT WAS NOTED TO BE DOING WELL. THE CAUSE OF THE PATIENT''S DIAGNOSES WAS NOT DETERMINED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194938 HEALON DUET OVDS LZP ABBOTT MEDICAL OPTICS 10-2900-80 UM30116

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention BSS - MANUFACTURER: B. BRAUN