Z-0188-2019Class I

CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF...

Name: Z-0188-2019 CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF...
Creator: Alcon Research, LTD.
Published: 2018-08-28
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2018-08-28 / Terminated / root cause: design

FDA source

Alcon Research, LTD. began a recall of CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use on 2018-08-28. FDA classified it as Class I and gives the reason as "Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0188-2019
Classification: Class I
Status: Terminated
Initiated: 2018-08-28
Posted: 2018-10-23
Terminated: 2020-12-18
Recalling firm: Alcon Laboratories
Product: CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
Product code: OGO Intraocular Pressure Lowering Implant
Reason for recall: Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
Root cause tag: design
FDA root cause: Device Design
Action: The firm initiated their market withdrawal by letter on 08/28/2018. The firm requested surgeons immediately cease implantation of the device and return any unused product.
Quantity in commerce: 480 units
Distribution: Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Finland, Germany, Hong Kong, Iceland, Italy, Mexico, Peru, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Uruguay.
Product codes and lots: GTIN 00380657540105 All lot/serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0188-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0185-2019	Class I	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0186-2019	Class I	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0187-2019	Class I	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0188-2019	Class I	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23

Product code OGO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)