RXSIGHT INSERTION DEVICE

Description of Event or Problem

A SITE REPORTED TO RXSIGHT THAT A PATIENT EXPERIENCED NO REFRACTIVE CHANGES AFTER A LIGHT ADJUSTMENT. UPON EXAMINATION, THE LENS WAS NOTED TO BE IMPLANTED BACKWARDS. FURTHER LIGHT TREATMENTS HAVE BEEN POSTPONED AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

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