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Johnson & Johnson Surgical Vision, Inc. recalls Single-Use Packs, REF: OPO80
Recalled February 1, 2023 · FDA recall Z-1007-2023 · Johnson & Johnson Surgical Vision
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. · FDA Class II
Units
384
Sold at
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
Description
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.
Product
Single-Use Packs, REF: OPO80
Manufacturer(s)
Johnson & Johnson Surgical Vision, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →