VERION DIGITAL MARKER M

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. 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. A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT: SYSTEM WAS SUCCESSFULLY VERIFIED AFTER THE SURGERY DATE. MOST RECENT ONSITE VISIT FROM FIELD SERVICE ENGINEER PERFORMED AND SIGNED SERVICE INSTALLATION RECORD. SYSTEM MEETS SPECIFICATIONS AS PER SERVICE INSTALLATION RECORD. THERE IS NO ENTRY IN SERVICEMAX FOR THE REPORTED EVENT. NO ON-SITE VISIT BY AN FIELD SERVICE ENGINEER WAS IDENTIFIED. NO PART IS EXPECTED TO BE RETURNED TO MANUFACTURER FOR EVALUATION. A PHOTO PROVIDED BY THE CUSTOMER AND ATTACHED TO THE COMPLAINT CONFIRMS THE REPORTED ISSUE. THERE IS NO HARM TO ANY PATIENT AS THE REPORTED ISSUE IS NOT RELATED TO A SURGERY. THE ROOT CAUSE OF THE REPORTED ISSUE IS USER HANDLING AS THE USER HAS TO VERIFY THE REFERENCE IMAGE´S QUALITY DURING THE PLANNING PHASE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM SUCCESSFULLY REGISTERED THE POOR REFERENCE IMAGE IN THE UNKNOWN EYE OF A PATIENT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY.

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: (B)(4).