ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Mar 3, 2026 · Event occurred Feb 3, 2026
Report 3009026057-2026-00008 · MDR key 24496155
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
Additional Manufacturer Narrative
REVIEW OF PROCEDURE # (B)(6) SHOWS EYE MOVEMENT THROUGHOUT THE PROCEDURE. EYE MOVEMENT CAN CAUSE OR CONTRIBUTE TO THE REPORTED FULL THICKNESS ARCUATE INCISION. RECOMMEND REVIEWING PROPER DOCKING AND LOCKING TECHNIQUE. SYSTEM FUNCTIONED AS DESIGNED. THE WOUND WAS HYDRO SEALED AND PATIENT IS DOING WELL POST OP. NO FURTHER CLINICAL FOLLOW-UP REQUIRED.
Description of Event or Problem
ON (B)(6) 2026, WHILE CAS WAS ONSITE FOR SURGERY SUPPORT, DOCTOR ((B)(6)) REPORTED THAT FOR PROCEDURE ID # (B)(6), IT WAS NOTED AK #2 WAS FULL THICKNESS AFTER OPENING.