Z-0011-2019Class II

ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name...

Name: Z-0011-2019 ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name...
Creator: Ellex iScience, Inc.
Published: 2018-01-11
License: https://open.fda.gov/license/

Nova Eye Inc. / initiated 2018-01-11 / Terminated / root cause: manufacturing process

FDA source

Ellex iScience, Inc. began a recall of ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA... on 2018-01-11. FDA classified it as Class II and gives the reason as "Sterility failure found in one of the units in the lot". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0011-2019
Classification: Class II
Status: Terminated
Initiated: 2018-01-11
Posted: 2018-10-01
Terminated: 2018-10-02
Recalling firm: Nova Eye Inc.
Product: ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Product code: HMX Cannula, Ophthalmic
Reason for recall: Sterility failure found in one of the units in the lot.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm called their consignees on 1/11/2018 instructing them to quarantine unused devices and monitor the patients operated with the devices in this lot. The firm issued a letter dated 1/16/2018 via FedEx Express on 1/17/2018 informing them a potential issue had been identified and to segregate the product immediately.
Quantity in commerce: 90 units
Distribution: Distribution US nationwide and Switzerland.
Product codes and lots: Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0011-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0011-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01

Product code HMX

K080067Class IIIscience Interventional Ophthalmic MicrocatheterIscience Interventional / cleared 2008-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)