VERION REFERENCE UNIT

Description of Event or Problem

A NURSE REPORTED A CASE OF A BILATERAL TORIC INTRAOCULAR LENS EXPLANTED, AND INDICATED A DIAGNOSTIC CALCULATION ERROR CREATED AN UNEXPECTED REFRACTIVE OUT-COME. UPON ADDITIONAL FOLLOW UP, THE REPORTER WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

Additional Manufacturer Narrative

ROOT CAUSE: NO TECHNICAL ROOT CAUSE COULD BE DETERMINED. CONTRIBUTING FACTORS FOR REPORTED ISSUE COULD BE ATTRIBUTED TO A POOR DIAGNOSTIC IMAGE, USE OF A NON OPTIMIZED FORMULA DURING PLANNING, OR INCORRECT PATIENT DATA ENTRY. 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, AT THIS TIME THE CUSTOMER HAS INDICATED NO ADDITIONAL INFORMATION WILL BE PROVIDED. (B)(4).