LENSAR LASER SYSTEM-FS 3D
Received Mar 23, 2026 · Event occurred Mar 9, 2026
Report 3009026057-2026-00013 · MDR key 24664129
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, DOCTOR ((B)(6)) REPORTED TO CAS THAT HE HAD AN ANTERIOR CAPSULE RUN OUT AT THE BASE OF THE TORIC NUB DURING PROCEDURE ID (B)(6) ON (B)(6) 2026. SITE IS SEEKING REVIEW OF THE PROCEDURE.
Additional Manufacturer Narrative
REVIEW OF PROCEDURE FILES AND IMAGING SHOW THE CAPSULOTOMY STARTS ON FRAME 3 AS EXPECTED AND THE CAPSULOTOMY STARTS TO BREAK THROUGH INTO THE AC ON FRAME 5 AND COMPLETELY THROUGH ON FRAME 7.THERE IS NOTHING NOTEWORTHY ON THIS CASE. SYSTEM FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW-UP REQUIRED.