Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: Recalled by Alcon Research, Ltd. Due to The ULTRASERT Delivery System from certain lots have...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research, Ltd. directly.
Affected Products
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.
Quantity: 371 units
Why Was This Recalled?
The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System
Where Was This Sold?
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 ***
About Alcon Research, Ltd.
Alcon Research, Ltd. has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report