CLASS I Device recall · Reported 31 Oct 2018 · FDA Enforcement Report

CyPass System 241, Intraocular Pressure Lowering Implant recalled

Alcon Research is recalling CyPass System 241, Intraocular Pressure Lowering Implant, Cypass Micro-stent, Cypass, distributed nationwide in the US. The recall was initiated on 28 Aug 2018 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN: 00380657540013, 0080657540013, 20380657540017, 10380657540010, 00380657540013 All lot/serial numbers

Quantity recalled14264 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0186-2019
FDA event ID: 80931
Recalling firm: Alcon Research, Sinking Spring, PA
Classification: Class I
Status: Terminated
Recall initiated: 28 Aug 2018
FDA classified: 23 Oct 2018
Reported: 31 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

28 Aug 2018	Recall initiated by company
23 Oct 2018	Classified by FDA	+56 days
31 Oct 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN: 00380657540013, 0080657540013, 20380657540017, 10380657540010, 00380657540013 All lot/serial numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 80931

This product is part of a recall event; the main page for the event is CyPass System 241-S recalled by Alcon Research.

Reported	Class	Recall	Company	Reason	Where
31 Oct 2018	CLASS I	CyPass System 241-S recalled by Alcon Research	Alcon Research	Other	Nationwide
31 Oct 2018	CLASS I	CyPass Ultra System recalled by Alcon Research	Alcon Research	Other	Nationwide
31 Oct 2018	CLASS I	CyPass System 241, Intraocular Pressure Lowering Implant recalled	Alcon Research	Other	Nationwide

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