InjuryOOE
ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received May 28, 2026 · Event occurred May 18, 2026
Report 3009026057-2026-00026 · MDR key 25319713
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
Description of Event or Problem
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT THEY EXPERIENCED ANTERIOR CAPSULAR TEARS ON PROCEDURE IDS # (B)(6).
Additional Manufacturer Narrative
REVIEW OF PROCEDURE # (B)(6) DOES NOT SHOW INDICATION OF CAPSULAR TEAR. CAPSULOTOMY BEGINS ON FRAME 3 WITH COMPLETE BREAKTHROUGH ON FRAME 8. RECOMMEND REVIEWING CAPSULAR BUTTON REMOVAL TECHNIQUE. SYSTEM FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW UP REQUIRED.