ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Feb 2, 2026 · Event occurred Jan 8, 2026
Report 3009026057-2026-00002 · MDR key 24235171
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 #65 SHOWS THAT FRAGMENTATION BEGINS ON FRAME 14 AND COMPLETES ON FRAME 37. EYE MOVEMENT IS SEEN STARTING AT FRAME 12 AND CONTINUING THROUGHOUT THE PROCEDURE. THIS EYE MOVEMENT COULD LEAD TO THE REPORTED CAPSULAR RENT. SYSTEM FUNCTIONED AS DESIGNED NO ADDITIONAL POST OP TREATMENT WAS NEEDED OR FURTHER CLINICAL FOLLOW UP REQUIRED.
Description of Event or Problem
ON (B)(6) 2026, DOCTOR (B)(6) C21U) REPORTED TO CAS THAT DURING PROCEDURE ID #65, AFTER REMOVING THE CATARACT NUCLEUS, A LINEAR RENT ON THE POSTERIOR CAPSULE WAS NOTED.