BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON ENDOCOAT

    MDR report key: 4075866 · Received September 9, 2014

    Report

    Report Number
    3004750704-2014-00005
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZP
    PMA / PMN Number
    P110007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING RECORD REVIEW WAS CONDUCTED TO ADDRESS THE CANNULA DETACHMENT REPORTED. A REVIEW OF THE MANUFACTURING AND PACKAGING BATCH RECORDS FOR CHARACTERISTICS THAT WOULD POTENTIALLY RELATE TO THE CUSTOMER'S OBSERVATION WAS PERFORMED. REVIEW OF THE SYRINGE COMPONENT FOR ADHERENCE TO PRODUCT SPECIFICATION. REVIEW OF COMPLAINT HISTORY INDICATES THERE HAVE BEEN NO OTHER REPORTS OF CANNULA DETACHMENT FOR HEALON ENDOCOAT PRODUCT SINCE MANUFACTURING BEGAN AT LIFECORE IN 2011. BATCH RECORD REVIEW DETERMINED COMPONENTS WERE INSPECTED, EVALUATED, AND ACCEPTED PER LIFECORE SPECIFICATION. THE ROOT CAUSE OF THIS INCIDENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. RECORD REVIEW DETERMINED THERE WERE NO DEVIATIONS OR COMMENTS REGARDING CANNULA DETACHMENT. THE CUSTOMER CONFIRMED THAT THE CANNULA SUPPLIED WITH THE HEALON ENDOCOAT WAS NOT USED DURING THE PROCEDURE. THE INVESTIGATION INDICATED THAT THE LOT MET PRODUCT SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN FOR THE HEALON ENDOCOAT. BECAUSE THE LOT NUMBER IS UNKNOWN, THE EXPIRATION DATE CANNOT BE DETERMINED. BECAUSE THE LOT NUMBER IS UNKNOWN, THE MANUFACTURE DATE CANNOT BE DETERMINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION - LOT NUMBER IS 025344. EXPIRATION DATE IS 02/29/2016. MANUFACTURING DATE IS 03/10/2014. BATCH RECORD REVIEW DETERMINED COMPONENTS WERE INSPECTED, EVALUATED AND ACCEPTED PER SPECIFICATION PER THE THIRD PARTY MANUFACTURER, LIFECORE BIOMEDICAL LLC. RECORD REVIEW DETERMINED THAT THERE WERE NO DEVIATIONS OR COMMENTS REGARDING FINGER GRIP DETACHMENT. THE ROOT CAUSE OF THE COMPLAINT IS NOT LIKELY RELATED TO THE MANUFACTURING PROCESS. RECORD REVIEW DETERMINED COMPONENTS WERE INSPECTED, EVALUATED AND ACCEPTED PER LIFECORE SPECIFICATIONS. LIFECORE MANUALLY INSPECTS 100% OF PRODUCT FOR PROPER ASSEMBLY AND DAMAGED FINGER GRIPS AFTER SYRINGE ASSEMBLY. INVESTIGATION INDICATES NO TREND REPORTED IN THE COMPLAINT HISTORY DUE TO FINGER GRIP DETACHMENT. NO CHANGES HAVE BEEN MADE TO THE HANDLING, MANUFACTURING PROCESS, OR RAW MATERIALS THAT WOULD CONTRIBUTE TO THIS OCCURRENCE. THE INVESTIGATION INDICATES THAT THE LOT MEETS THE PRODUCT SPECIFICATION. A CERTIFICATE OF ANALYSIS WAS PROVIDED BY THE THIRD PARTY MANUFACTURER (LIFECORE BIOMEDICAL, LLC). PER THE CERTIFICATE, THE ACTUAL BIOLOGICAL SPECIFICATIONS WERE ALL WITHIN SPECIFICATIONS. MODEL NUMBER IS VT585U. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA ''CAME OFF'' A HEALON ENDOCOAT SYRINGE WHEN THE PHYSICIAN WAS INJECTING THE VISCOELASTIC. THE GUARD WAS IN PLACE AND PREVENTED SEPARATION AS THE SNAP ON THE PROTECTOR CAUGHT THE CANNULA; HOWEVER, THERE WAS ENOUGH POSTERIOR MOVEMENT OF THE CANNULA TO RUPTURE THE CAPSULE. IT WAS ALSO NOTED THAT A TENSION RING WAS USED DURING THE PROCEDURE TO ASSIST IN STABILIZATION OF THE CAPSULE. IN ADDITION, MIOCHOL WAS INJECTED TO EFFECT NORMAL TONUS. POST¿OPERATIVELY, THE PATIENT RECEIVED THE FOLLOWING PRESCRIPTIONS: ALPHAGAN AND PROLENSA. ONE DAY POST-OP, PATIENT PRESENTED WITH CORNEAL EDEMA. PATIENT IS SCHEDULED TO RETURN FOR A FOLLOW-UP AFTER 1-2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552066 HEALON ENDOCOAT OVDS LZP ABBOTT MEDICAL OPTICS VT585U 025344

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention TENSION RING