Z-0429-2007

AcrySof ReSTOR Intraocular Lens

Name: Z-0429-2007 AcrySof ReSTOR Intraocular Lens
Creator: Alcon Laboratories, Inc
Published: 2006-12-14
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2006-12-14 / Terminated

FDA source

Alcon Laboratories, Inc began a recall of AcrySof ReSTOR Intraocular Lens on 2006-12-14. The reason FDA records is "Intraocular lenses exposed to extreme temperatures while in storage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0429-2007
Status: Terminated
Initiated: 2006-12-14
Posted: 2007-02-15
Terminated: 2008-04-09
Recalling firm: Alcon Laboratories
Product: AcrySof ReSTOR Intraocular Lens
Product code: MFK Lens, Multifocal Intraocular
Reason for recall: Intraocular lenses exposed to extreme temperatures while in storage.
FDA root cause: Other
Action: The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006.
Quantity in commerce: 4 units
Distribution: Nationwide.
Product codes and lots: Model SN60D3, Serial numbers: 968290.039; 934317.012; 934317.013; and 948332.080.

Product code MFK

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