Alcon Laboratories Ireland, Ltd: Medical Device Recall in 2022 - (Recall #: Z-1269-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Alcon Clareon IOL with AutonoMe Delivery System

Product Classification:

Class II

Date Initiated: May 11, 2022

Date Posted: June 29, 2022

Recall Number: Z-1269-2022

Event ID: 90194

Reason for Recall:

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

Status: Terminated

Product Quantity: 139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)

Code Information:

Catalog/Model Number: CNA0T0.175 UDI Code: (01) 00380652393669 (17) 240720 (21) 25238769000 (11) 210722 (240) CNA0T0175 Lot number: 25238769 Catalog/Model Number: CNA0T0.240 UDI Code: (01) 00380652393799 (17) 240720 (21) 25238775000 (11) 210722 (240) CNA0T0240 Lot Number: 25238775

Distribution Pattern:

U.S.: AL, CA, FL, GA, IA, IL, KY, LA, MI, MO, NY, OH,OK, TX, VA, and WI O.U.S.: Czech Republic, France, Germany, India, Slovakia, Spain, and Switzerland

Voluntary or Mandated:

Voluntary: Firm initiated