BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON ENDOCOAT

    MDR report key: 11008995 · Received December 15, 2020

    Report

    Report Number
    3004750704-2020-00070
    Event Type
    Injury
    Date Received
    December 15, 2020
    Report Date
    January 14, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    PMA / PMN Number
    P110007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION INCLUDES: ¿REVIEW OF THE MANUFACTURING BATCH RECORD FOR THOSE CHARACTERISTICS THAT WOULD POTENTIALLY RELATE TO THE OBSERVATIONS. ¿REVIEW OF THE PRODUCT TESTING TO CONFIRM, SPECIFICATION ADHERENCE (STERILITY, PARTICULATES, PH, ENDOTOXIN, AND OSMOLALITY). ¿REVIEW OF THE COMPLAINT DATABASE FOR SIMILAR REPORTED EVENTS . CONCLUSION: BASED ON THE REVIEW OF THE BATCH RECORDS AND MANUFACTURING PROCESS, THIS OCCURRENCE IS LIKELY, NOT ASSOCIATED WITH A MANUFACTURING ASSIGNABLE CAUSE. REVIEW OF THE COMPLAINT DATABASE INDICATES, THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS FOR LOT 028715. THIS COMPLAINT APPEARS TO BE AN ISOLATED INCIDENT. RECOMMENDATIONS: SINCE THE ROOT CAUSE IS LIKELY, NOT RELATED TO THE MANUFACTURING PROCESS. AND THE REPORT DOES NOT INDICATE A TREND. NO FURTHER ACTIONS ARE RECOMMENDED AT THIS TIME. LIFECORE WILL CONTINUE TO MONITOR AND TREND COMPLAINTS OF THIS TYPE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. IMPLANT DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. EXPLANT DATE: NOT APPLICABLE AS THIS IS NOT AN EXPLANTABLE DEVICE. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED REPORT FROM A DOCTOR'S OFFICE WHICH INDICATED THREE OF THEIR PATIENTS EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THEY PROVIDED THE TWO LOT NUMBERS INVOLVED IN THE THREE CASES. HOWEVER, AT THE TIME OF THIS REPORT THEY DID NOT INDICATE WHICH LOT NUMBER CORRELATED WITH WHICH PATIENT. FOLLOW-UP WAS PERFORMED TO GET ADDITIONAL DETAILS. HOWEVER THE CUSTOMER ONLY PROVIDED THE DOCTORS NAMES AND INDICATED THAT DR. (B)(6) HAD TWO PATIENTS AND DR. (B)(6) HAD ONE PATIENT. DR. (B)(6) EVENT IS CAPTURED IN THIS MEDWATCH REPORT FOR ONE PATIENT WHICH WE WILL REFER TO AS PATIENT #1 FOR LOT 028715. AS DESCRIBED ABOVE, THE PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). ALTHOUGH NOT SPECIFIED, IT¿S IMPORTANT TO NOTE THE REPORTED EVENT NORMALLY REQUIRES MEDICAL INTERVENTION TO RESOLVE. NO FURTHER INFORMATION WAS PROVIDED. THE OTHER COMPLAINTS ARE CAPTURED IN ANOTHER MDR REPORTS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478309 HEALON ENDOCOAT OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. VT585U 028715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention