MalfunctionMSS
RXSIGHT INSERTION DEVICE
Received May 27, 2026
Report 3012712027-2026-00232 · MDR key 25306165
Device
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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
A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL) WAS INADVERTENTLY IMPLANTED BACKWARDS. THE SITE COMPLETED ALL LIGHT TREATMENTS FOR THE PATIENT BEFORE REALIZING THAT THE ORIENTATION OF THE LAL WAS INCORRECT. THE SURGEON BELIEVES THAT HE WAS NOT ROTATING THE HANDPIECE ENOUGH DURING OPTIC DELIVERY. HOWEVER, THE PATIENT IS HAPPY WITH THEIR CURRENT VISION, AND THERE IS NO PLAN TO EXCHANGE OR REPOSITION THE LENS AS YAG CAPSULOTOMY WAS COMPLETED.