Surgical vision packs with defective welds may affect cataract surgery outcomes
Johnson & Johnson is recalling 384 single-use phacoemulsification packs due to weld defects that may cause surgical delays and corneal swelling during cataract surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical device with manufacturing defects that could result in surgical complications including corneal edema. No illnesses or injuries reported; hazard is risk-of-harm based on product defect without documented patient harm.
Plain-English summary
Johnson & Johnson Surgical Vision, Inc. is recalling 384 single-use phacoemulsification packs (REF: OPO80, Lot 05050474573352/60326033) used in cataract surgery. The packs have weld defects and physical gaps between the housing and pack cover that may exceed design specifications.
These defects could prevent the priming cycle from completing properly and may reduce the vacuum delivered to surgical handpieces during the procedure. This could result in surgical delays, extended surgical time, and increased risk of transient corneal edema (swelling of the cornea).
The affected units have been distributed in the United States (Florida, Mississippi, New York, Tennessee, Texas, Illinois, Minnesota, Ohio) and internationally to Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, and the United Kingdom.
No illnesses or injuries have been reported. Affected facilities should stop using these packs and contact Johnson & Johnson Surgical Vision for replacement units or further instructions.
The recalled product
- Product
- Single-Use Packs, REF: OPO80
- Manufacturer
- Johnson & Johnson Surgical Vision, Inc.
- Hazard
- defective-weld
- priming-failure
- corneal-edema-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI/Lot: 05050474573352/60326033
Distribution
Distributed in 8 states:
- FL
- IL
- MN
- MS
- NY
- OH
- TN
- TX
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