VERION DIGITAL MARKER M

Additional Manufacturer Narrative

ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO INFORMATION HAS BEEN RECEIVED. AN INTRAOCULAR LENS (IOL) WRONGLY IMPLANTED BY 90 DEGREES COULD LIKELY BE A RESULT OF A WRONG SELECTED DOCTOR POSITION SINCE THIS MATCHES THE SCALING OF SELECTING THE DOCTOR POSITION. THE DEVICE IN THIS CASE IS NOT ABLE TO REGISTER THE DIAGNOSTIC IMAGE TO THE PATIENT'S IMAGE WHICH RESULTED IN A WRONG REGISTRATION ANGLE. FURTHERMORE, THE USER IS REQUIRED TO VERIFY THAT THE REFERENCE IMAGE DOES MATCH WITH THE PATIENT'S REAL IMAGE BY COMPARING THE VESSEL STRUCTURES IN THE BLENDING SCREEN. MOST LIKELY THE ROOT CAUSE IS USE ERROR, BUT COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4)

Description of Event or Problem

ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO INFORMATION HAS BEEN RECEIVED.

Additional Manufacturer Narrative

EVENT OCCURRED (B)(6) 2017 AND NOT (B)(6) 2017 AS ORIGINALLY REPORTED. 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. (B)(4).

Description of Event or Problem

A DOCTOR REPORTED INCORRECT INTRAOCULAR LENS (IOL) PLACEMENT POST IMAGE GUIDED CATARACT PROCEDURE. REPORTER INDICATED THE PATIENT HAD TO UNDERGO A SECONDARY SURGICAL PROCEDURE TO REPOSITION THE IOL BY 90 DEGREES.