ITRACK ADVANCE
Received May 7, 2026
Report 3005641545-2026-00010 · MDR key 25108533
Device
Generic name
Canaloplasty Microcatheter Kit With Advanced Delivery System
Manufacturer
Nova Eye, Inc.Model number
ITRACK-ADSCatalog number
203000
Lot number
2512-04
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
SUPERONASAL DESCEMET MEMBRANE DETACHMENT OCCURRED DURING ITRACK ADVANCE PROCEDURE. RIGHT EYE, OBSERVED DURING CATHETER RETRACTION PAST THIS SITE. REPAIR PROCEDURE CARRIED OUT (AIR BUBBLE). POST-OP, THE PATIENT TREATED WITH ADDITIONAL SF6 BUBBLE REPAIR PROCEDURE WITHIN THE FIRST WEEK. FOLLOW UP INFORMATION INDICATES SOME RESIDUAL SMALL FOLD, EXPECTED TO STRAIGHTEN OVER TIME.