InjuryOOE
ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Mar 10, 2026 · Event occurred Feb 17, 2026
Report 3009026057-2026-00010 · MDR key 24557375
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 PROCEDURE #(B)(6) DOES NOT SHOW ANY INDICATION OF RADIAL CAPUSULAR TEAR. CAPSULOTOMY BEGINS ON FRAME 3 WITH COMPLETE BREAKTHROUGH ON FRAME 8. RECOMMEND REVIEW OF CAPSULAR BUTTON REMOVAL TECHNIQUE. SYSTEM FUNCTIONED AS DESIGNED.NO FURTHER CLINICAL FOLLOW-UP REQUIRED.
Description of Event or Problem
ON (B)(6) 2026, WHILE CAS WAS ON-SITE FOR SURGERY SUPPORT, DOCTOR (B)(6)) NOTED THAT PROCEDURE ID #(B)(6) HAD A RADIAL CAPSULAR TEAR.