ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Apr 14, 2026 · Event occurred Mar 22, 2026
Report 3009026057-2026-00014 · MDR key 24872183
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
- Corneal Perforation
Narrative
Additional Manufacturer Narrative
REVIEW OF PROCEDURE ID# (B)(4) STILL IMAGING FRAME 31 AND VIDEO DOES NOT SHOW BUBBLES ON THE POSTERIOR OF THE CORNEA WHICH INDICATES NO APPARENT SIGN OF THE ARCUATE BREAKING THROUGH THE POSTERIOR OF THE CORNEA. SYSTEM FUNCTIONED AS DESIGNED. ONE SUTURE WAS PLACED AND PATIENT IS DOING WELL POST OP. NO FURTHER CLINICAL FOLLOW-UP REQUIRED.
Description of Event or Problem
ON 03/22/2026, DOCTOR ((B)(6)) REPORTED TO CAS THAT DURING PROCEDURE ID #(B)(4), HE EXPERIENCED A LEAKING FULL THICKNESS ARCUATE.