ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received May 4, 2026 · Event occurred Dec 5, 2025
Report 3009026057-2026-00020 · MDR key 25067271
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
- Corneal Perforation
Narrative
Description of Event or Problem
ON (B)(6) 2026, WHILE CAS WAS ON SITE FOR SURGERY SUPPORT, DOCTOR ((B)(6)) REPORTED THAT THEY NOTED A FULL THICKNESS AK DURING PROCEDURE ID # (B)(6). THIS PROCEDURE WAS PERFORMED ON (B)(6) 2025.
Additional Manufacturer Narrative
REVIEW OF PROCEDURE ID# (B)(6) VIDEO AND IMAGING SHOWS PATIENT MOVEMENT DURING THE FIRST PART OF PROCEDURE AND RIGHT AFTER AK WAS MADE CHANGING EYE POSITIONING FROM THE POINT OF SCANNING. 1 ARCUATE INCISION OF 70 DEGREE @ 35 WAS PROGRAMMED WITH A 600 MICRON FIXED DEPTH AND RESIDUAL 150 MICRON BED DEPTH WITH ENERGY AT 3.0UJ. BUBBLES APPEAR TO BE IN THE ANTERIOR CHAMBER AFTER THE ARCUATE WAS MADE INDICATING POTENTIAL POSTERIOR PENETRATION OF THE CORNEA IN THAT REGION. RECOMMEND REVIEW OF LOCKING PATIENT AND PAUSING TREATMENT DURING MOVEMENT AND ADJUSTING AK DEPTH TO 80% AND ENERGY TO 2.8UJ. SYSTEM FUNCTIONED AS DESINGED. NO FURTHER CLINICAL FOLLOW UP IS REQUIRED.