Abbott Sovereign Compact Phacoemulsification System Recalled for Vacuum Loss Risk
Abbott Medical Optics is recalling 534 Sovereign Compact Phacoemulsification Systems because they may lose vacuum tone mode during cataract surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (potential loss of vacuum during surgery) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Abbott Medical Optics, Inc. (AMO) has initiated an urgent notice of medical device correction and advisory notice for the Sovereign Compact Phacoemulsification System, Version 5.3. The recall involves 534 systems that were distributed worldwide, including in the United States, Latin America, EMEA, and APAC regions.
The recall was issued because the systems have the potential to lose the vacuum tone mode during surgery. This device is used for cataract surgery. The affected systems are identified by specific serial number formats depending on the manufacturing facility: Sanmina-SCI Corporation (starting February 2012) uses the format YYYY35XXX, and AMO Manufacturing USA, LLC in Milpitas, CA (starting February 2013) uses the format YYYY80XXX.
Customers who use these systems should contact Abbott Medical Optics for further instructions on the correction. The agency classification for this recall is Class II.
The recalled product
- Product
- Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
- Manufacturer
- Abbott Medical Optics, Inc.
- Affected units
- 534
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Name: Sovereign¿ Compact Console Universal
- Sanmina-SCI Corporation
- LLC facility in Milpitas
Distribution
Distributed nationwide across the United States.
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