FDA-Device2023-02-01Class II
Single-Use Packs, REF: OPO80
Johnson & Johnson Surgical Vision, Inc.
Hazard
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, 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.
Sold states
US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, United Kingdom
Affected count
384
Manufactured in
31 Technology Dr Ste 200, N/A, Irvine, CA, United States
Products
Single-Use Packs, REF: OPO80
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1007-2023Don't want to check this manually?
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