FDA-Device2022-10-19Class II
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Johnson & Johnson Surgical Vision, Inc.
Hazard
As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.
Sold states
Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL IN, KY LA, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, VA, and WA; Australia, Azerbaijan, Belgium, Brazil, Canada, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan, Jordan, Kuwait, Morocco, Netherlands, New Zealand, Oman, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom
Affected count
53,624 units
Manufactured in
31 Technology Dr Ste 200, N/A, Irvine, CA, United States
Products
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0086-2023Don't want to check this manually?
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