Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA Recalled by Abbott Medical Optics, Inc. Due to Under specific conditions, there is an unlikely potential...
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. directly.
Affected Products
STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Quantity: 1,882, total all systems
Why Was This Recalled?
Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Medical Optics, Inc.
Abbott Medical Optics, Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report