Agency classClass IOur severity:Critical FDA (Devices)·Z-0188-2019·Announced 2018-10-31

Alcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss

Alcon is recalling the CyPass Micro-Stent implant 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it represents a reasonable probability of serious adverse health consequences.

Plain-English summary

Alcon Research, LTD. is recalling the CyPass System 241, Intraocular Pressure Lowering Implant, specifically the CYPASS MICRO-STENT and CYPASS APPLIER (REF: 8065754010). The recall involves 480 units distributed worldwide, including the United States, Puerto Rico, and numerous international locations. All lot and serial numbers are affected.

The recall was initiated after an 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 a group that underwent cataract surgery alone. This finding suggests a potential risk to eye health for patients who have received this specific implant.

Patients who have had the CyPass Micro-Stent implanted should contact their eye care provider to discuss these findings and determine the appropriate next steps for their care. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recalled product

Product: CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
Manufacturer: Alcon Research, LTD.
Category: Medical Device — Ophthalmic Implant
Hazard: endothelial-cell-loss
Affected units: 480

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 (1)

GTIN 00380657540105 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 →

Same manufacturer · Alcon Research, LTD.

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Same hazard · endothelial cell loss