Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sovereign¿ Compact Phacoemulsification System Recalled by Abbott Medical Optics, Inc. Due to Abbott Medical Optics Inc. (AMO) initiated this Urgent...
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
Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Quantity: 534 systems
Why Was This Recalled?
Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign¿ Compact Phacoemulsification System, Version 5.3, because it has the potential to lose the vacuum tone mode during surgery.
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