InjuryOOE
LENSAR LASER SYSTEM-FS 3D
Received Mar 10, 2026 · Event occurred Feb 18, 2026
Report 3009026057-2026-00009 · MDR key 24557348
Device
Generic name
Lensar Laser System-fs 3d
Manufacturer
Lensar, Inc.Model number
N/ACatalog number
70-00005-001
Lot number
N/A
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Capsular Bag Tear
Narrative
Description of Event or Problem
ON (B)(6) 2026, WHILE CAS WAS ON-SITE FOR SURGERY SUPPORT, DOCTOR ((B)(6)) REPORTED THAT DURING PROCEDURE ID#(B)(6), THEY EXPERIENCED AN ANTERIOR CAPSULE TEAR THAT RAN TO THE POSTERIOR CAPSULE.
Additional Manufacturer Narrative
A REVIEW OF PROCEDURE ID#(B)(6) SHOWS THE CAPSULOTOMY BREAK THROUGH IS IN TWO FRAMES. THERE IS NO PATIENT EYE MOVEMENT OR INDICATION OF AN ISSUE WITH THE PROCEDURE THAT WOULD CONTRIBUTE TO A CAPSULAR TEAR. SYSTEM FUNCTIONED AS DESIGNED.NO FURTHER CLINICAL FOLLOW-UP REQUIRED.