FUSION Dual Pump Packs, REF: OPO73
Recall
- Recall Number
- Z-1006-2023
- Event Number
- 91290
- Firm
- Johnson & Johnson Surgical Vision, Inc.
- FEI Number
- 3012236936
- Product Code
- HQC
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- December 7, 2022
- Posted
- January 20, 2023
- Address
- 31 Technology Dr, Ste 200, Irvine, CA, 92618-2302
Description
FUSION Dual Pump Packs, REF: OPO73
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.
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 [email protected] 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.
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
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