ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received May 7, 2026 · Event occurred Apr 15, 2026
Report 3009026057-2026-00018 · MDR key 25116086
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 A RADIAL TEAR AT THE "JUNCTION OF THE TORIC CAPSULE NUB" DURING PROCEDURE ID # (B)(6).
Additional Manufacturer Narrative
REVIEW OF PROCEDURE #(B)(6) DOES NOT REVEAL ANY EVIDENCE OF A RADIAL TEAR AT THE REPORTED LOCATION. THE CAPSULOTOMY IS OBSERVED TO BEGIN ON FRAME 3, WITH FULL BREAKTHROUGH ACHIEVED BY FRAME 7. IT IS RECOMMENDED THAT THE CAPSULAR BUTTON REMOVAL TECHNIQUE BE REVIEWED. THE SYSTEM FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW UP IS REQUIRED.