BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON ENDOCOAT

    MDR report key: 7284776 · Received February 20, 2018

    Report

    Report Number
    3004750704-2018-00020
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    January 18, 2018
    Report Date
    July 26, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZP
    UDI-DI
    05050474547063
    PMA / PMN Number
    P110007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: UNKNOWN, NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE PRODUCT IS NOT IMPLANTABLE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE PRODUCT IS NOT IMPLANTABLE. DEVICE MANUFACTURE DATE: UNKNOWN, NOT PROVIDED. INCISION ENLARGEMENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO (B)(4), INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHADOWY/BLOB WAS NOTICED INTO THE PATIENT'S EYE WHILE INJECTING THE VISCOELASTIC ENDOCOAT. REPORTEDLY, IT COULD NOT BE ASPIRATED OUT WITH THE I/A (IRRIGATION/ASPIRATION) OR THE PHACO HANDPIECE. IT WOULD REPEL WHATEVER TOUCHED IT AND IT WAS VERY STICKY. THEY ENDED UP LEAVING IT IN THE EYE AND IT DISSOLVED AFTER A FEW DAYS. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED EPINEPHRINE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE INCISION WAS ENLARGED. A CAPSULAR TENSION RING WAS IMPLANTED TOGETHER WITH A SYMFONY ZXR00 +22.0 DIOPTER. TO DATE THE LENS REMAINS IMPLANTED. NO VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126436 HEALON ENDOCOAT OVDS LZP ABBOTT MEDICAL OPTICS VT585U 026930 05050474547063

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention