BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 20894225 · Received December 10, 2024

    Report

    Report Number
    2184002-2024-00007
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    October 30, 2024
    Report Date
    March 10, 2025
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS D.4, D.9, H.3, H.6 AND H.11. A FACILITY REPRESENTATIVE REPORTED AS BOTH LOT NUMBERS 030657 & 030434- THE VISCOAT SYRINGE WOULDN'T SNAP TOGETHER CORRECTLY. THEY HAD TO BE REPLACED WITH ANOTHER SYRINGE. THEY NEED REPLACED OR REFUNDED AS PER THEIR REQUEST. COMPLAINT LOT SEARCH REPORT REVIEWED; 7 COMPLAINTS HAVE BEEN REPORTED. THERE ARE NO SIMILAR COMPLAINTS. VISCOAT WAS PACKAGED AS VISCOAT SINGLES (LFG-9900056, LOT 030434) AND WITHIN A DUOVISC CONFIGURATION (LFG-9900076, LOT030436). BATCH RECORD REVIEW: SYRINGE ASSEMBLY OF VISCOAT LOT 030434 OCCURRED FROM 15DEC2023 TO 22DEC2023. THERE WERE NO NONCONFORMANCES NOR COMMENTS RELATED TO DAMAGED COMPONENTS. PERCENT DEFECTIVE RATE WAS WITHIN THE ALLOWABLE REJECT PERCENTAGE. PROCESSES ARE IN PLACE TO DETECT AND REMOVE DEFECTS RELATED TO DAMAGED COMPONENTS THROUGHOUT THE PACKAGING ACTIVITIES. THE REJECT CHALLENGE WAS PERFORMED AT THE BEGINNING OF EVERY SHIFT TO ENSURE THESE PROCESSES WERE FUNCTIONING. RECORD REVIEW DETERMINED THERE WERE NO DEVIATIONS RELATED TO SYRINGE ASSEMBLY THAT WOULD INDICATE AN ISSUE WITH DAMAGED UNITS. THE SYRINGE ASSEMBLER CONSISTS OF FIVE SYRINGE ASSEMBLY FUNCTIONS; LABEL PRINTING AND VERIFICATION, FILLED SYRINGE LABEL APPLICATION, SYRINGE SLEEVE ORIENTING AND SYRINGE INSERTION, PLUNGER ROD ORIENTING AND ASSEMBLY, AND PRODUCT DISPOSITION/SORTING STATION. AT EACH OF THESE STEPS THERE ARE APPLICABLE SENSORS AND MECHANISMS TO IDENTIFY AND MECHANICALLY DIVERT NONCONFORMING SYRINGES FROM THE ASSEMBLY PATH. NONCONFORMING SYRINGES DETECTED BY SENSORS ARE AUTOMATICALLY DIVERTED FROM THE ACCEPTABLE PATH TO A REJECTION BIN. SYRINGE UNITS ARE 100% VISUALLY INSPECTED POST-FILL PER (B)(4), VISUAL INSPECTION DEFECT CRITERIA. SYSTEMS ARE IN PLACE TO DETECT DEFECTS AND THE PROCESS WORKED AS INTENDED. THERE WERE NO DEVIATIONS FOR LOT 030434 THAT RESULTED IN REJECTED UNITS PRIOR TO RELEASE, ALL REJECT RATES WERE WITHIN THE ALLOWABLE REJECT PERCENTAGE AND NO TRENDS WERE OBSERVED. THE QCI INSPECTIONS PERFORMED AT SECONDARY PACKAGING (PER ANSI/ASQC Z-1.4, SPECIAL, LEVEL S-4, AQL0.65, SINGLE) AND AT FINAL PACKAGING PRIOR TO RELEASE (PER ANSI/ASQC Z-1.4, SPECIAL, LEVEL S-4, AQL0.15, TIGHTENED) PASSED THE INSPECTIONS AND NO TRENDS WERE OBSERVED. RAW MATERIAL EVALUATION: NO NONCONFORMITIES OR DEVIATIONS HAVE BEEN NOTED FOR RAW MATERIAL LOTS RELATED TO SYRINGE ASSEMBLY FOR VISCOAT LOT 030434: PLUNGER ROD LRM-9810559-1 LOT 2349385. SYRINGE SLEEVE LRM-9810560-1 LOT 2350176 AND 2349013. SYRINGE SLEEVE CAP LRM-9810994-1 LOT 2348869. PER THE MANUFACTURER QUALITY AGREEMENT SECTION 7.7, LIFECORE IS NOT REQUIRED TO RETEST OR REINSPECT MATERIAL SUPPLIED BY MANUFACTURER BESIDES CONFIRMING THE IDENTITY AND PACKAGE INTEGRITY UPON RECEIPT. EVALUATION OF RETURN PRODUCT DEMONSTRATED SYRINGES NOT SEATED PROPERLY IN SLEEVE. COMPONENTS (RAW MATERIALS) SHOWED NO EVIDENCE OF DAMAGE. THERE IS A SENSOR ON THE EQUIPMENT THAT IDENTIFIES WHEN A CAP IS PARTIALLY SEATED OR UNSEATED IN THE SYRINGE SLEEVE. IT IS MOST PROBABLE THAT THE SENSOR WAS NOT WORKING AS INTENDED DURING ASSEMBLY IF NONCONFORMING PRODUCT MADE IT IN THE PRODUCT STREAM. THE SENSOR WAS VERIFIED TO BE IN OPERATING CONDITION ON 19MAR2024 TO ENSURE IT WAS OPERATING IN A STATE OF CONTROL. IT WAS IDENTIFIED ON 19MAR2024 THAT THIS PART OF THE SENSOR IS NOT IN THE PROCEDURE TO BE TESTED DURING THE REJECT CHALLENGE PERFORMED EVERY SHIFT. THE REJECT CHALLENGE PROCEDURE WAS UPDATED TO INCLUDE TESTING THIS SENSOR WITH AN EFFECTIVE DATE OF 04MAY2024. VISCOAT 030434 WAS SEALED INTO VISCOAT SINGLES LOT 030434. LIFECORE HAS NO REMAINING INVENTORY OF VISCOAT LSA-9850113 OR LFG-9900056 LOT 030434. IT WAS MANUFACTURED ON 23OCT2023. (B)(4) UNITS WERE RELEASED ON 29MAR2024 AND SHIPPED IN ITS ENTIRETY FROM LIFECORE ON 02APR2024 RETENTION SAMPLE TESTING IS NOT REQUIRED BASED ON ASSESSMENT PERFORMED IN (B)(4). IT IS LIKELY THAT THE SLEEVE CAP REJECT SENSOR WAS NOT WORKING AS INTENDED DURING ASSEMBLY. THE SYRINGE WAS NOT PROPERLY ASSEMBLED DURING MANUFACTURING AND WAS NOT CAUGHT DURING LIFECORE'S INSPECTION PROCEDURES. IT IS MOST PROBABLE THAT THE SENSOR WAS NOT WORKING AS INTENDED DURING ASSEMBLY IF NONCONFORMING PRODUCT MADE IT IN THE PRODUCT STREAM. THE SENSOR WAS VERIFIED TO BE IN OPERATING CONDITION ON 19MAR2024 TO ENSURE IT WAS OPERATING IN A STATE OF CONTROL. IT WAS IDENTIFIED ON 19MAR2024 THAT THIS PART OF THE SENSOR IS NOT IN THE PROCEDURE TO BE TESTED DURING THE REJECT CHALLENGE PERFORMED EVERY SHIFT. THE REJECT CHALLENGE PROCEDURE WAS UPDATED TO INCLUDE TESTING THIS SENSOR WITH AN EFFECTIVE DATE OF 04MAY2024. REVIEW OF THE LOT COMPLAINT HISTORY, PRODUCT SPECIFICATIONS AND MANUFACTURING RECORD FOUND NO ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. BASED ON ANALYSIS PERFORMED, NO ATYPICAL TREND IS PRESENT FOR THE REPORTED LOT. IN THE ABSENCE OF AN ATYPICAL COMPLAINT TREND AND AS NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED DURING THE INVESTIGATION, THIS COMPLAINT IS NOT JUSTIFIED FROM A TECHNICAL POINT OF VIEW. NO FURTHER ACTION IS REQUIRED. THE REJECT CHALLENGE PROCEDURE WAS UPDATED TO INCLUDE TESTING THE UPPER PART OF THE SLEEVE CAP SENSOR WITH AN EFFECTIVE DATE OF 04MAY2024. THE COMPLAINT TREND IS BEING FURTHER EVALUATED IN CASE INVESTIGATION 45347/CAPA 58483. MONTHLY TREND REPORTING FOR COMPLAINTS WAS REVIEWED AND NO ADVERSE TREND WAS IDENTIFIED FOR THE REPORTED EVENT CODE(S) FOR THE PRODUCT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT AN OPHTHALMIC CANNULA SYRINGE WOULD NOT SNAP TOGETHER CORRECTLY. THE PROCEDURE WAS COMPLETED WITH ALTERNATIVE SYRINGE. DETAILS OF PROCEDURE WAS NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534251 VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP LIFECORE BIOMEDICAL, LLC NA 030434

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown