Z-2323-2015Class I

ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric...

Name: Z-2323-2015 ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric...
Creator: Alcon Research, Ltd.
Published: 2015-04-15
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2015-04-15 / Terminated / root cause: manufacturing process

FDA source

Alcon Research, Ltd. began a recall of ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses... on 2015-04-15. FDA classified it as Class I and gives the reason as "There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2323-2015
Classification: Class I
Status: Terminated
Initiated: 2015-04-15
Posted: 2015-08-07
Terminated: 2017-06-30
Recalling firm: Alcon Laboratories
Product: ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.
Product code: HQL Intraocular Lens
Reason for recall: There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Alcon Research sent recall notification letters dated April 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using the affected product and place on hold until their sales representatives visit their site for withdrawal. Follow up communication activities included personal contact via phone and site visits. For questions regarding this recall call 817-293-0450.
Quantity in commerce: 45,391
Distribution: Distribution Japan, No US distribution.
Product codes and lots: Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2323-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2323-2015	Class I	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-07

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)