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Abbott Medical Optics, Inc. recalls Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Recalled July 17, 2013 · FDA recall Z-1670-2013 · Abbott Medical Optics
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. · FDA Class II
Units
534 systems
Sold at
Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.
Description
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.
Product
Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Manufacturer(s)
Abbott Medical Optics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →