BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON PRO

    MDR report key: 7637105 · Received June 26, 2018

    Report

    Report Number
    3004750704-2018-00042
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    May 25, 2018
    Report Date
    November 5, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    UDI-DI
    05050474614758
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION (RETAINED LOT): PRODUCT TESTING WAS PERFORMED ON RETAINED SAMPLE SINCE THE PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. VISUAL INSPECTION WITH STEREOMICROSCOPY ON RETAINED PRODUCTS ON HEALON PRO LOT UD31217 WAS PERFORMED. THERE NO VISIBLE DEFECTS WERE FOUND ON THE PACKAGE, CANNULA OR SOLUTION. THE SOLUTION WAS CLEAR AND COLORLESS. ALL COMPONENTS WERE INCLUDED IN THE PRODUCT WITHOUT DEFECTS. CANNULA WAS WITHOUT DAMAGE. THERE WERE NO VISIBLE DEFECTS ON THE PRODUCT BOX. THE PRINTING ON THE CARTON AND LABELS ARE CORRECT. FUNCTIONAL TEST WAS ALSO PERFORMED. THE OVD (OPHTHALMIC VISCOSURGICAL DEVICE) SOLUTION WAS EXPELLED IN A CONTROLLED AND SMOOTH MANNER FROM TWO (2) REFERENCE SYRINGES. THE PRODUCT PERFORMED AS EXPECTED. PRODUCT DEFICIENCY WAS NOT FOUND ON RETAIN SAMPLES. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO COMPLAINTS HAVE PREVIOUSLY BEEN REPORTED ON THIS BATCH. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). HEALON IS NOT AN IMPLANTABLE DEVICE. EXPLANT DATE: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). HEALON IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HEALON PRO WAS DIFFICULT TO REMOVE FROM THE RIGHT EYE AND THE PATIENT EXPERIENCED HEADACHE 1 HOUR POST-OP. THE PATIENT¿S INTRAOCULAR PRESSURE ALSO SPIKED AT 55MMHG. THE DOCTOR HAD TO WITHDRAW THE VISCOELASTIC THROUGH A SIDE PORT INCISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. THE PATIENT IS NOW FEELING BETTER. THERE WAS NO TREATMENT OR PRESCRIPTION GIVEN BY THE DOCTOR OUTSIDE OF THE NORMAL POST-OPERATIVE TREATMENT. THERE WAS NO OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481939 HEALON PRO OVDS LZP JOHNSON AND JOHNSON SURGICAL VISION, INC. TH55ML UD31217 05050474614758

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention