VERION DIGITAL MARKER M

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. DATA COLLECTION WAS RECEIVED AND THE DATA WAS INVESTIGATED. IT WAS DETERMINED THAT USER ERROR LEAD TO THE MISALIGNMENT OF THE LENS. THE SELECTED SUPERIOR ORIENTATION ON THE PLANNING SCREEN DOES NOT MATCH THIS ORIENTATION OF THE EYE. FOLLOWED BY A WRONG REGISTRATION PROPOSAL CONFIRMED OR MANUALLY SET, THIS LEAD TO A WRONG TORIC ALIGNMENT OVERLAY. USER ERROR, DUE TO INCORRECT MICROSCOPE ORIENTATION AND INCORRECT REGISTRATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

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).

Description of Event or Problem

A CUSTOMER REPORTED THAT IT WAS LATER FOUND THAT A PATIENT'S VISUAL ACUITY HAD BEEN UNABLE TO BE PROPERLY ADJUSTED DUE TO AXIS DEVIATION AFTER INSERTION OF A TORIC INTRAOCULAR LENS FOLLOWING THE GUIDANCE DISPLAYED BY THE SYSTEM. IT IS UNKNOWN IF THE DEVIATION WAS CAUSED BY THE CONSOLE OR THE USER. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES PATIENT SIX AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE OTHER PATIENTS.