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Johnson & Johnson Surgical Vision, Inc. recalls VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Recalled August 9, 2023 · FDA recall Z-2247-2023 · Johnson & Johnson Surgical Vision
Hazard
Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema. · FDA Class II
Units
148,941
Sold at
Worldwide - US Nationwide distribution including in the states of NC, OH, NY, IN, FL, TN, CA, PA, AZ, AL, TX, WA, WV, MS, GA, UT, KY, IA, MO, AR, DE, IL, WI, VA, NJ, LA, SC, HI, OR, VT, MN, NV, CO and the countries of Argentina, Australia, Austria, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Korea¿(South), Kuwait, Lebanon, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela.
Description
Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Product
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Manufacturer(s)
Johnson & Johnson Surgical Vision, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →