ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Jul 20, 2026 · Event occurred Jun 23, 2026
Report 3009026057-2026-00032 · MDR key 25872997
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) SHOWS CLEAN BREAKTHROUGH OF THE CAPSULOTOMY AND BOTH INTELLI-AXIS NUBS CREATED AS PLANNED. ANY ISSUE WITH TORIC NUB MAY HAVE OCCURRED DURING CATARACT REMOVAL PORTION OF THE PROCEDURE. NOTHING REMARKABLE NOTED ON VIDEO AND IMAGING OF THE PROCEDURE THAT WOULD INDICATE A CAUSE FOR AN ANTERIOR CAPSULE TEAR. SYSTEM FUNCTIONED AS DESIGNED. THE PATIENT HAD A VICTRECTOMY DONE AND IS RECOVERING WELL. NO FURTHER CLINICAL FOLLOW UP REQUIRED.
Description of Event or Problem
ON 06/23/2026, DOCTOR (B)(6) REPORTED TO CAS THAT WHILE DOING A VISCO REMOVAL DURING PROCEDURE ID#: (B)(6), NOTED THAT THERE WAS A TORIC NUB ON THE TEMPORAL SIDE. SITE IS SEEKING REVIEW.