RXSIGHT CONTACT LENS

Additional Manufacturer Narrative

MANUFACTURER REFERENCE #: (B)(4).

Description of Event or Problem

RXSIGHT BECAME AWARE OF A PATIENT WHO DEVELOPED CORNEAL ULCERS. THE PATIENT ATTRIBUTES THE CORNEAL ULCERS TO A "MISHANDLING" OF THE CONTACT LENS USED DURING LIGHT TREATMENT. THE PATIENT ALSO NOTES THAT THE DOCTOR OR CLINIC ATTRIBUTES THE CORNEAL ULCERS TO THE PATIENT'S ANTERIOR BASEMENT MEMBRANE DYSTROPHY (ABMD).