ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Jul 20, 2026 · Event occurred Jul 7, 2026
Report 3009026057-2026-00034 · MDR key 25873180
Device
Generic name
Ally Adaptive Cataract Treatment System
Manufacturer
Lensar, Inc.Model number
N/ACatalog number
70-00050-001
Lot number
N/A
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Capsular Bag Tear
Narrative
Additional Manufacturer Narrative
REVIEW OF PROCEDURE (B)(6) SHOWS PATIENT MOVEMENT DURING THE CAPSULOTOMY. THIS MOVEMENT COULD CONTRIBUTE TO THE REPORTED CAPSULAR TEAR. REVIEW OF PROCEDURE (B)(6) DOES NOT SHOW ANY INDICATION OF CAPSULAR TEAR. CAPSULOTOMY BEGINS ON FRAME 3 WITH BREAKTHROUGH ON FRAME 7. THE EYE IS WELL CENTERED AND NO MOVEMENT IS SEEN. RECOMMEND REVIEWING THE IMPORTANCE OF NO PATIENT MOVEMENT DURING THE PROCEDURE. IT IS ALSO RECOMMENDED THAT TREATMENT PAUSE AND ABORT BE REVIEWED WITH THE USER. SYSTEM FUNCTIONED AS DESIGNED. NO CLINICAL FOLLOW UP REQUIRED.
Description of Event or Problem
ON (B)(6) 2026, DOCTOR (B)(4) REPORTED TO (B)(6) THAT THEY HAD CAPSULOTOMY TEARS ON PROCEDURE IDS (B)(6) AND (B)(6). SITE IS SEEKING REVIEW OF THE CASES.