BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASHEVILLE EYE ASSOCIATES 2.4 BACK TABLE CATARACT

    MDR report key: 23670519 · Received November 28, 2025

    Report

    Report Number
    1211998-2025-00017
    Event Type
    Injury
    Date Received
    November 28, 2025
    Date of Event
    November 11, 2025
    Report Date
    February 13, 2026
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HOZ
    UDI-DI
    0088615803741517271017
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVOLVES THE OBSERVATION OF WHITE FOREIGN MATERIAL IN PATIENTS' EYES DURING THE ONE-DAY POSTOPERATIVE VISIT FOLLOWING SURGICAL PROCEDURES IN WHICH A BVI CUSTOM PROCEDURE PACK WAS USED. THREE PATIENTS WERE IMPACTED, AND THE FOREIGN MATERIAL WAS SURGICALLY REMOVED. THE PATIENTS CONTINUE TO BE MONITORED, AND NO LONG-TERM ADVERSE OUTCOMES HAVE BEEN REPORTED. A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE AFFECTED LOT CONFIRMED THAT THE PRODUCT WAS MANUFACTURED, INSPECTED, AND RELEASED IN ACCORDANCE WITH APPROVED SPECIFICATIONS AND ESTABLISHED MANUFACTURING AND ENVIRONMENTAL CONTROL PROCEDURES. NO EVIDENCE OF CONTAMINATION, PROCESS DEVIATIONS, OR QUALITY SYSTEM NONCONFORMITIES WAS IDENTIFIED. ADDITIONALLY, NO RELATED QUALITY NOTIFICATIONS, CAPAS, OR UNAPPROVED CHANGE CONTROLS WERE FOUND. ALTHOUGH NO PHYSICAL SAMPLES FROM THE AFFECTED LOT WERE AVAILABLE FOR EVALUATION, IN-PROCESS COMPONENTS WITH THE SAME PART NUMBERS BUT DIFFERENT LOT NUMBERS WERE ASSESSED. THIS EVALUATION CONFIRMED THAT BOTH THE ORIGINALLY SPECIFIED GAUZE AND THE SUBSTITUTED GAUZE CONTAIN FIBERS; HOWEVER, THE SUBSTITUTED GAUZE COMPONENT EXHIBITED A HIGHER LEVEL OF FIBER SHEDDING. THE SUBSTITUTION WAS IMPLEMENTED UNDER AN APPROVED CONCESSION, AND THE INVESTIGATION DETERMINED THAT THE POTENTIAL IMPACT OF THIS MATERIAL CHANGE ON OPHTHALMIC USE WAS NOT SUFFICIENTLY EVALUATED PRIOR TO APPROVAL. THE INVESTIGATION CONCLUDED THAT THE REPORTED CONDITION IS ATTRIBUTABLE TO INCREASED FIBER SHEDDING ASSOCIATED WITH THE SUBSTITUTED GAUZE MATERIAL RATHER THAN A FAILURE OF MANUFACTURING PROCESSES, ENVIRONMENTAL CONTROLS, OR PRODUCT RELEASE ACTIVITIES. CORRECTIVE ACTIONS HAVE BEEN DEFINED TO REVISE CONCESSION CONTROLS AND PREVENT THE USE OF THE SUBSTITUTED GAUZE MATERIAL IN THE AFFECTED KIT CONFIGURATION. CORRECTIONS HAVE BEEN MADE IN SECTION D: D1 BRAND NAME UPDATED FROM GAUZE SPONGE, 16-PLY, 4 X 4 IN / 10.2 X 10.2 CM TO ASHEVILLE EYE ASSOCIATES 2.4 BACK TABLE CATARACT D2A COMMON DEVICE NAME UPDATED FROM GAUZE SPONGE, 16-PLY, 4 X 4 IN / 10.2 X 10.2 CM TO ASHEVILLE EYE ASSOCIATES 2.4 BACK. TABLE CATARACT. D2C UPDATED FROM CODE NAB TO HOZ. D4 CATALOG NUMBER UPDATED FROM 6030099 TO 58002376. NO OTHER CHANGES WERE MADE TO THIS SUBMISSION.

    Description of Event or Problem · 0

    THE COMPLAINT CONCERNS AN INCIDENT INVOLVING A BACK-TABLE PACK CONTAINING GAUZE SUPPLIED WITHIN THE CUSTOMEYES KIT. FOLLOWING USE OF THIS PACK DURING OPHTHALMIC PROCEDURES, THREE PATIENTS WERE FOUND TO HAVE WHITE DEBRIS IN THE EYE AT THEIR ONE-DAY POSTOPERATIVE VISIT. THE SURGEONS BELIEVE THE DEBRIS ORIGINATED FROM THE GAUZE MATERIAL, WHICH THEY DESCRIBED AS LOOSE AND PRONE TO SHEDDING FIBERS. ALL THREE PATIENTS REQUIRED A RETURN TO SURGERY FOR FOREIGN BODY REMOVAL. ADDITIONAL SYMPTOMS INCLUDED OCULAR IRRITATION. PATIENTS ARE BEING MONITORED AND ARE USING POSTOPERATIVE EYE DROPS. THE COMPLAINT WAS INITIALLY RAISED AGAINST PACK 58002376 - (B)(6) 2.4 BACK TABLE CATARACT, LOT 6095015. HOWEVER, THE CUSTOMER IDENTIFIED THE AFFECTED COMPONENT AS THE GAUZE WITH PART NUMBER 6030099 (GAUZE SPONGE, 16-PLY, 4 X 4 IN / 10.2 X 10.2 CM). THEREFORE, THE REPORT WILL BE SUBMITTED FOR THE AFFECTED COMPONENT, PART NUMBER 6030099. BECAUSE THREE PATIENTS WERE AFFECTED, SEPARATE REPORTS WILL BE SUBMITTED FOR EACH PATIENT. BASED ON THE INFORMATION PROVIDED, THE EVENT MEETS THE DEFINITION OF A SERIOUS INJURY UNDER FDA REGULATIONS. EACH PATIENT REQUIRED SURGICAL INTERVENTION TO REMOVE DEVICE-RELATED FOREIGN MATERIAL FROM THE EYE. SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY STRUCTURE CONSTITUTES A SERIOUS INJURY AS DEFINED IN 21 CFR 803.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186984 ASHEVILLE EYE ASSOCIATES 2.4 BACK TABLE CATARACT ASHEVILLE EYE ASSOCIATES 2.4 BACK TABLE CATARACT HOZ BEAVER-VISITEC INTERNATIONAL, INC. N/A 6095015 0088615803741517271017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention