Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Intraocular Lens (IOL) Recalled by Aaren Scientific, Incorporated Due to Aaren Scientific is recalling intraocular lenses because the...
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 Aaren Scientific, Incorporated directly.
Affected Products
Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification.
Quantity: 28 units
Why Was This Recalled?
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
Where Was This Sold?
This product was distributed to 4 states: AL, FL, KS, OK
About Aaren Scientific, Incorporated
Aaren Scientific, Incorporated has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report