FUSION Dual Pump Packs, REF: OPO73
- Recall Initiated
- December 7, 2022
- Posted
- January 20, 2023
- Recall Number
- Z-1006-2023
- Quantity
- 7644
- Firm Location
- Irvine, CA
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
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
Lot / Code Info
UDI-DI/Lots: 15050474602080/60373238, 60394037, 60308197
Root Cause
Process control
Action Taken
On 12/07/22, recall notices were sent to customers who were asked to do the following: 1) Discontinue using affected product. 2) Return product to the recalling firm. 3) Complete and return the Customer Reply form via email to RegCompliOne@its.jnj.com 4) Distributors, distribute the recall notice to your customers. Customers with questions or concerns can call the firm at 1-877-266-4543 Option 2.