VERION DIGITAL MARKER M

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE MANUFACTURER'S PRODUCT SUBJECT MATTER EXPERT CONCLUDED THAT THE SURGEON HAD SET AN INCORRECT MICROSCOPE ORIENTATION LEADING TO THE AXIS BEING DISPLAYED AT A DIFFERENT POSITION FOR THE FIRST SURGERY. HOWEVER, DURING THE TOUCH UP SURGERY, SURGEON HAS CORRECTED THIS AND SELECTED THE CORRECT MICROSCOPE ORIENTATION AND REALIGNED THE LENS. THE COMPANY REPRESENTATIVE IS AWARE OF THE FINDINGS AND WILL INFORM THE FINDINGS AND RETRAIN THE CUSTOMER ON THE IMPORTANCE OF SELECTING THE CORRECT ORIENTATION. NO SAMPLE IS EXPECTED TO BE RETURNED FOR EVALUATION. THE INVESTIGATION IS THEREFORE CONCLUDED BASED ON THE PROVIDED INFORMATION. THE ROOT CAUSE IS AN INCORRECT MICROSCOPE ORIENTATION SELECTED AT THE START OF SURGERY, CAUSING THE AXIS TO BE DISPLAYED AT A DIFFERENT POSITION (I.E., USER HANDLING), SYSTEM MET SPECIFICATIONS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT A RESIDUAL ERROR WITH POST OPERATIVE TREATMENT RESULTS WAS LESS THAN ONE DIOPTER, THE AXIS OFFSET BY NINETY DEGREES (OUT OF RANGE) IN THE LEFT EYE OF A PATIENT, AFTER SURGERY. AFTER SEVERAL ATTEMPTS TO ALIGN THE EYE AND WAS OFTEN OUT OF RANGE.

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).