BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON5 PRO

    MDR report key: 12587168 · Received October 6, 2021

    Report

    Report Number
    2020664-2021-07533
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    June 20, 2021
    Report Date
    November 16, 2021
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    05050474701632
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3 DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE MATERIAL WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: INFORMATION UNKNOWN/ NOT PROVIDED. IMPLANT DATE: N/A. THE HEALON IS NOT AN IMPLANTABLE DEVICE. EXPLANT DATE: N/A. THE HEALON IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PARTICLE WAS OBSERVED DURING USE OF HEALON 5 PRO. THE SMALL PARTICLE WAS INJECTED TOGETHER WITH THE HEALON5 PRO INTO THE PATIENTS EYE. THERE WAS A DELAY IN PROCEDURE; HOWEVER, NO MEDICAL OR SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE REQUIRED. IT WAS INDICATED THAT THE DAILY ACTIVITIES OF THE PATIENT WAS NOT SIGNIFICANTLY AFFECTED AND THAT THE PATIENT HAS FULLY RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480559 HEALON5 PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB UH31521 05050474701632

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown