Recall Z-1006-2023 ยท HQC Unit, Phacofragmentation
Johnson & Johnson Surgical Vision, Inc.
FUSION Dual Pump Packs, REF: OPO73
| Date | Jan 20, 2023 (initiated Dec 7, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| 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 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. |
| Quantity | 7644 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160236 | Dual Pump Pack Abbott Medical Optics, Inc., Apr 27, 2016 |