Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AMO Sensar Intraocular Lenses (IOLs) Recalled by Abbott Medical Optics Inc (AMO) Due to Mislabeling

Date: December 20, 2012
Company: Abbott Medical Optics Inc (AMO)
Status: Terminated
Source: FDA (Device)

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 Abbott Medical Optics Inc (AMO) directly.

Affected Products

AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.

Quantity: 155 units

Why Was This Recalled?

Two production orders of these IOLs that contain mislabeled IOLs.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Medical Optics Inc (AMO)

Abbott Medical Optics Inc (AMO) has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report