ORA SYSTEM WITH VERIFEYE MESSAGING

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).

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE EXPLANTED INTRAOCULAR LENS, WITH THE PATIENT EXPERIENCING A MYOPIC REFRACTIVE SURPRISE AND A POST-OPERATIVE ACHIEVED MANIFEST REFRACTIVE SPHERICAL EQUIVALENT TREATMENT VALUE OF ONE DIOPTER IN THE LEFT EYE, WAS DUE TO SYSTEM-SUGGESTED INACCURATE READINGS/MEASUREMENTS DURING REFRACTIVE SURGERY.