The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0186-2019·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.

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 System 241, Intraocular Pressure Lowering Implant, specifically the CYPASS MICRO-STENT and CYPASS APPLIER (REF: 8065754001). This medical device is intended for ophthalmic use. The recall affects 14,264 units distributed worldwide, including the United States, Puerto Rico, and numerous international locations such as Argentina, Australia, Canada, and the United Kingdom.

The recall was initiated following an analysis of the completed dataset from the COMPASS-XT long-term study. The data indicated that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to a group that underwent cataract surgery alone. Endothelial cell loss is a condition affecting the cornea that can impact vision.

Patients who have had this implant placed should contact their eye care provider to discuss the findings and determine appropriate next steps. The recall covers all lot and serial numbers for the specified reference number.

The recalled product

Product
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
Manufacturer
Alcon Research, LTD.
Category
Medical Device — Ophthalmic Implant
Hazard
Affected units
14,264

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 (5)

  • GTIN: 00380657540013
  • 0080657540013
  • 20380657540017
  • 10380657540010
  • 00380657540013 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 →

Related recalls

Same manufacturer · Alcon Research, LTD.

See all →

Same hazard · endothelial cell loss

See all →

Similar recalls