ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received May 28, 2026 · Event occurred May 5, 2026
Report 3009026057-2026-00022 · MDR key 25319176
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
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Capsular Bag Tear
Narrative
Additional Manufacturer Narrative
REVIEW OF SURGICAL IMAGES FOR PROCEDURE #(B)(6) SHOWS CAPSULOTOMY BEGINS ON FRAME 3 WITH COMPLETE BREAKTHROUGH ON FRAME 8. THERE IS NO INDICATION OF CAPSULAR TEAR SEEN. RECOMMEND REVIEWING CAPSULAR BUTTON REMOVAL TECHNIQUE. SYSTEM FUNCTIONED AS DESIGNED. THE PATIENT WAS REFERRED TO RETINA FOR FURTHER EVALUATION. THE PATIENT IS DOING FINE POSTOPERATIVELY.
Description of Event or Problem
ON (B)(6) 2026, WHILE CAS WAS ON-SITE FOR SURGERY SUPPORT, DOCTOR (B)(6) REPORTED THAT THEY EXPERIENCED A CAPSULAR TEAR AT 12O'CLOCK FOLLOWING PROCEDURE ID # (B)(6).