Reported Jun 29, 2022 · Terminated

Alcon Clareon IOL with AutonoMe Delivery System

Alcon Laboratories Ireland, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alcon Laboratories Ireland, Ltd · Cork Business And Technology Park · Cork · N/A

Is this the product you have?

  • Alcon Clareon IOL with AutonoMe Delivery System
Lot codes and dates
  • Catalog/Model NumberCNA0T0.175
  • UDI Code(01) 00380652393669 (17) 240720 (21) 25238769000 (11) 210722 (240)
  • CNA0T0175 Lot number25238769
  • Catalog/Model NumberCNA0T0.240
  • UDI Code(01) 00380652393799 (17) 240720 (21) 25238775000 (11) 210722 (240)
  • CNA0T0240 Lot Number25238775
Amount recalled
139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)

Where it was sold

Why it was recalled

Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 5, 2025 · Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.