Single-Use Packs recall
Single-Use Packs, REF: OPO80
Why was Single-Use Packs recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI/Lot: 05050474573352/60326033
- Product
- Single-Use Packs, REF: OPO80
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Quantity
- 384
- Distribution
- 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
- Recall date
- February 1, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)