The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0187-2019·Announced 2018-10-31

Alcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss

Alcon Research is recalling the CyPass Micro-Stent because long-term study data showed statistically significant endothelial cell loss in patients who received the device.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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 cataract surgery alone."

Plain-English summary

Alcon Research, LTD. is recalling the CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, and CYPASS APPLIER (REF CATALOG #: 8065754007) for ophthalmic use. The recall involves 38,682 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets. All lot and serial numbers are affected.

The recall was initiated after analysis of the completed dataset from the COMPASS-XT long-term study indicated that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.

Patients who have had this device implanted should contact their eye care provider for further evaluation and guidance.

The recalled product

Product
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
Manufacturer
Alcon Research, LTD.
Category
Medical Device — Ophthalmic
Hazard
Affected units
38,682

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • GTIN: 00380657540075
  • 10380657540072
  • 20380657540079 All lot/serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Alcon Research, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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