InjuryOOE
ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Feb 18, 2026 · Event occurred Feb 3, 2026
Report 3009026057-2026-00005 · MDR key 24377055
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 Incompatibility
Patient
NA · Unknown
- Corneal Perforation
Narrative
Description of Event or Problem
ON (B)(6) 2026, DOCTOR ((B)(4)) REPORTED TO CAS THAT THEY HAD A FULL THICKNESS AK ON PROCEDURE ID #(B)(6).
Additional Manufacturer Narrative
REVIEW OF PROCEDURE #(B)(6) SCHEIMPFLUG IMAGING NOTES BUBBLE ON EDGE OF SECOND AK. LASER ADJUSTED TO ACCOMMODATE THE THINKER CORNEA. SURGEON MAY CONSIDER CHANGING SETTINGS TO 80-85% DEPTH INSTEAD OF A FIXED 600 MICRON DEPTH TO MINIMIZE RISK OF THIN POSTERIOR CORNEA POST ARCUATE. SYSTEM FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW-UP REQUIRED.