VERION DIGITAL MARKER M

Additional Manufacturer Narrative

SAMPLE WAS NOT RETURNED. NO INFORMATION ABOUT THE DEVICE OR SERIAL NUMBER WAS PROVIDED. NO CONTACT INFORMATION PROVIDED; THEREFORE, UNABLE TO OBTAIN FURTHER FOLLOW UP INFORMATION. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED, BASED ON THE INFORMATION PROVIDED. (B)(4).

Description of Event or Problem

AN OPHTHALMOLOGIST REPORTED AN INTRAOCULAR LENS (IOL) AXIS WAS INCORRECTLY ALIGNED ON AN EYE. REPORTER INDICATED A SECONDARY PROCEDURE WAS PERFORMED TO RELOCATE THE IOL TO THE CORRECT AXIS. ADDITIONAL INFORMATION IS UNAVAILABLE.

Additional Manufacturer Narrative

NO INFORMATION ABOUT THE REPORTED DEVICE WAS PROVIDED. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED, BASED ON THE INFORMATION PROVIDED. GENERALLY, AN UNSTABLE OVERLAY CAN BE SEEN IF ILLUMINATION IS TOO DARK OR MICROSCOPE ZOOM LEVEL NOT APPROPRIATE DURING SURGERY. IN SUCH AN EVENT THE SURGEON WOULD NOT BE ABLE TO ACCURATELY SEE TO ALIGN THE LENS. (B)(4).