InjuryMPA
ITRACK ADVANCE
Received May 7, 2026
Report 3005641545-2026-00008 · MDR key 25108527
Device
Generic name
Canaloplasty Microcatheter Kit With Advanced Delivery System
Manufacturer
Nova Eye, Inc.Model number
ITRACK-ADSCatalog number
203000
Lot number
2506-14
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Eye Injury
Narrative
Description of Event or Problem
NASAL DESCEMET MEMBRANE DETACHMENT OCCURRED DURING ITRACK ADVANCE PROCEDURE. RIGHT EYE, OBSERVED POST OP. CONSERVATIVE TREATMENT CARRIED OUT. SMALL HAEMOSIDERIN STAIN ON CORNEA WHICH IS EXPECTED TO RESOLVE.
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.