InjuryMSS
RXSIGHT INSERTION DEVICE
Received Jul 21, 2026 · Event occurred Jun 23, 2026
Report 3012712027-2026-00323 · MDR key 25893547
Device
Product problems
- Insufficient Device Problem Information
Patient
69 YR · Female
- Capsular Bag Tear
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY. MANUFACTURER REFERENCE #: 17231.
Description of Event or Problem
A SITE REPORTED THAT, DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL), THE LENS WAS INADVERTENTLY IMPLANTED BACKWARDS. THE SURGEON WAS ABLE TO FLIP THE LAL TO THE CORRECT ORIENTATION; HOWEVER, A CAPSULAR BAG TEAR OCCURRED. A VITRECTOMY WAS PERFORMED, AND THE LAL WAS SUBSEQUENTLY IMPLANTED IN THE SULCUS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.