FDA-Device2013-07-17Class II
Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Abbott Medical Optics, Inc.
Hazard
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.
Sold states
Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.
Affected count
534 systems
Manufactured in
510 Cottonwood Dr, N/A, Milpitas, CA, United States
Products
Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1670-2013Don't want to check this manually?
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