Z-2708-2016Class II

Alcon AcrySof IQ IOL with ULTRASERT Delivery System

Name: Z-2708-2016 Alcon AcrySof IQ IOL with ULTRASERT Delivery System
Creator: Alcon Research, Ltd.
Published: 2016-07-28
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2016-07-28 / Terminated / root cause: manufacturing process

FDA source

Alcon Research, Ltd. began a recall of Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior... on 2016-07-28. FDA classified it as Class II and gives the reason as "The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System". 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-2708-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-28
Posted: 2016-09-01
Terminated: 2017-06-07
Recalling firm: Alcon Laboratories
Product: Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.
Product code: HQL Intraocular Lens
Reason for recall: The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Alcon Research sent an Urgent Field Safety Notice letter dated July 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check their inventory and segregate any product being recalled. Customers were asked to complete and return the Field Safety Notice Response Form. For questions or concerns contact Alcon.
Quantity in commerce: 371 units
Distribution: Armenia, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Italy, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Slovenia, Spain, Sweden, Switzerland, Thailand, United Kingdom (Great Britain and Ireland), and United Arab Emirates. *** While this product is available in the US, these lots were not distributed to US consignees ***
Product codes and lots: Lot numbers: 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, 12409028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2708-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2708-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-09-01

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)