VERION DIGITAL MARKER M

Additional Manufacturer Narrative

H.3., H.6.: 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: 2023-59933.

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT THE SURGICAL FIELD UNDER A MICROSCOPE WAS DARK AND THE CONTRAST WAS POOR DUE TO THE INSTALLATION OF THE MICROSCOPE INTEGRATED DISPLAY, DURING CATARACT SURGERY WITH NO PATIENT HARM.

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED SERIAL NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE DEVICE ON THE FIELD HAS UNDERGONE PREVENTIVE MAINTENANCE ACTIVITIES CONFIRMING THAT IT HAS BEEN WORKING WITHIN SPECIFICATIONS. THE RETURNED COMPONENT WAS TESTED AND THE REPORTED EVENT COULD NOT BE REPLICATED. MULTIPLE TEST SURGERIES AND CALIBRATIONS COULD BE PERFORMED WITHOUT ANY ISSUES. THEREFORE, IT IS CONCLUDED THAT THE DEVICE MEETS SPECIFICATIONS AND THE COMPLAINT IS RELATED TO CUSTOMER DISSATISFACTION. THE SAMPLE EVALUATION SHOWED THAT THE RETURNED DEVICE MEETS SPECIFICATIONS. THE REPORTED INCIDENT COULD THEREFORE NOT BE CONFIRMED AND CONSEQUENTLY NO ROOT CAUSE WAS IDENTIFIED. THIS INCIDENT IS CLASSIFIED AS CUSTOMER DISSATISFACTION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).