FUSION Dual Pump Packs, REF: OPO73
FDA Recall Z-1006-2023 · Posted 2023-01-20
Advertisement
Recalling FirmJohnson & Johnson Surgical Vision, Inc.
Recall StatusOpen, Classified
Product CodeHQC
Date Initiated2022-12-07
Product Quantity7644
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.
Firm Action
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.
Root Cause
Process control
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement