Device product
FUSION Dual Pump Packs, REF: OPO73
Z-1006-2023
Product summary
- Event
- Event 91290
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7644
- Official record key
device-enforcement:Z-1006-2023
Official wording
Reason: 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.
Code information: UDI-DI/Lots: 15050474602080/60373238, 60394037, 60308197
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
Derived failure modes
-
Unknown
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.