Z-2441-2008

MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton...

Name: Z-2441-2008 MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton...
Creator: Alcon Laboratories, Inc
Published: 2008-07-07
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2008-07-07 / Terminated / root cause: labeling and UDI

FDA source

Alcon Laboratories, Inc began a recall of MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort... on 2008-07-07. The reason FDA records is "Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2441-2008
Status: Terminated
Initiated: 2008-07-07
Posted: 2008-09-23
Terminated: 2009-08-26
Recalling firm: Alcon Laboratories
Product: MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract removal. Each cartridge is imprinted with the model type on the wing of the Monarch II cartridge which can be visually verified prior to use.
Product code: KYB Lens, Guide, Intraocular
Reason for recall: Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: The recalling firm notified healthcare professional consignees and affiliated foreign distributors by letter on 07/07/08 and advised of the mislabeled device and potential hazard associated with delivery of the IOL. Consignees were instructed to return identified lots in their inventory and to return the enclosed business reply card for product replacement. Contact Stericycle Inc at 1-800-668-4391 for assistance with returning the recalled product. Contact Alcon Customer Service at 1-800-862-5266 for questions about the recall.
Quantity in commerce: 7962 units
Distribution: Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
Product codes and lots: Lot 174249 Exp 07/2010 Lot 174250 Exp 07/2010 and Lot 174244 Exp 07/2010

Product code KYB

K001157Class IMonarch II IOL Delivery SystemAlcon Research, Ltd. / cleared 2000-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)