ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Feb 18, 2026 · Event occurred Jan 28, 2026
Report 3009026057-2026-00004 · MDR key 24377100
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
Description of Event or Problem
ON (B)(6) 2026, WHILE CAS WAS ON SITE FOR SURGERY SUPPORT, DOCTOR (B)(6) REPORTED A FULL THICKNESS AK (#2) ON PROCEDURE ID #(B)(4).
Additional Manufacturer Narrative
REVIEW OF PROCEDURE #(B)(4) PROCEDURE IMAGES AND SURGICAL VIDEO DOES NOT APPEAR TO SHOW SIGNS OF POSTERIOR BREAK THROUGH ON ARCUATE #2. NO BUBBLES APPEAR TO FORM UNDER THE CORNEA DURING THE PROCEDURE AND ONE BUBBLE ANTERIOR TO THE CORNEA IS RELEASED. SURGEON MAY HAVE PERFORATED THE POSTERIOR CORNEA WHILE OPENING THE ARCUATE DURING THE CATARACT REMOVAL PORTION OF THE SURGERY. SYSTEM FUNCTIONED AS DESIGNED. A BCL WAS PLACED DURING THE PROCEDURE. BCL REMOVED 1 DAY PO. PATIENT IS DOING WELL. NO FURTHER CLINICAL FOLLOW-UP REQUIRED.