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

THE SITE REPORTED THAT FOLLOWING COMPLETION OF LIGHT ADJUSTMENT TREATMENTS, THE PATIENT EXPERIENCED MINIMAL CHANGE IN REFRACTION AND COMPLAINED OF GLARE AND HALOS IN THE LEFT EYE. UPON EXAMINATION, THE IMPLANTED LIGHT ADJUSTABLE LENS (LAL) WAS OBSERVED TO BE IMPLANTED BACKWARDS. THE SITE REPORTED THAT THE PATIENT WAS SATISFIED WITH THEIR VISION AND THERE IS NO SURGICAL INTERVENTION PLANNED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.