MalfunctionMSS
RXSIGHT INSERTION DEVICE
Received Jun 3, 2026 · Event occurred May 6, 2026
Report 3012712027-2026-00253 · MDR key 25375538
Device
Generic name
Rxsight Insertion Device
Manufacturer
Rxsight, Inc.Model number
63001Catalog number
63001
Lot number
0011
Product problems
- Insufficient Device Problem Information
Patient
61 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MANUFACTURER REFERENCE NUMBER: (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.