MalfunctionMSS
RXSIGHT INSERTION DEVICE
Received Apr 16, 2026
Report 3012712027-2026-00171 · MDR key 24899191
Device
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MANUFACTURER REFERENCE #: (B)(4).
Description of Event or Problem
A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL) FLIPPED TO AN INCORRECT ORIENTATION DURING IMPLANTATION. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.