Z-1007-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2023
- Initiation Date
- December 7, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 384
Product Description
Single-Use Packs, REF: OPO80
Reason for Recall
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.
Distribution Pattern
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
Code Information
UDI-DI/Lot: 05050474573352/60326033