ITRACK ADVANCE
Received Mar 18, 2026 · Event occurred Feb 18, 2026
Report 3005641545-2026-00003 · MDR key 24635852
Device
Generic name
Canaloplasty Microcatheter Kit With Advanced Delivery System
Manufacturer
Nova Eye, Inc.Model number
ITRACK-ADSCatalog number
203000
Lot number
2509-10
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Eye Injury
Narrative
Additional Manufacturer Narrative
FOREIGN INCIDENT. NON-USA UDI ASSOCIATED WITH THIS INCIDENT DUE TO TRANSLATED LABELLING PROVIDED OUS. DEVICE IS EQUIVALENT TO THAT SOLD IN USA.
Description of Event or Problem
SURGEON PERFORMED CANALOPLASTY AND 180-DEGREE GATT PROCEDURE, AS WELL AS CATARACT SURGERY. WHEN THE SURGEON WENT TO PUT IN THE MAIN INCISION FOR THE CATARACT, A DESCEMET'S DETACHMENT WAS NOTICED. IT HAD STARTED TO CURL UP. NO OVD APPEARED TO BE IN THE DESCEMET'S. AN AIR BUBBLE REPAIR WAS CARRIED OUT.