RXSIGHT INSERTION DEVICE

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY. MANUFACTURER REFERENCE #: (B)(4).

Description of Event or Problem

A SITE REPORTED TO RXSIGHT THAT DURING A POST-OPERATIVE FOLLOW-UP VISIT, A PATIENT WAS FOUND TO HAVE A LIGHT ADJUSTABLE LENS (LAL) IMPLANTED IN A BACKWARDS ORIENTATION IN THE RIGHT EYE. THE LAL HAD BEEN IMPLANTED DURING A PROCEDURE WHERE A NON-RXSIGHT MULTIFOCAL IOL WAS EXCHANGED FOR THE LAL; THIS PROCEDURE WAS REPORTEDLY DIFFICULT DUE TO IRIS PROLAPSE, POOR DILATION, AND OVERALL CHALLENGING INTRAOPERATIVE MANAGEMENT, BUT THE SURGEON WAS ULTIMATELY ABLE TO IMPLANT THE LAL. DUE TO THE INTRAOPERATIVE DIFFICULTIES ENCOUNTERED DURING THE EXCHANGE PROCEDURE, THE SURGEON DOES NOT WANT TO EXPLANT OR REPOSITION THE LAL, CONSIDERING SURGICAL INTERVENTION TO BE TOO CLINICALLY RISKY.