FDA Medical Device Recalls (openFDA)
Johnson & Johnson Surgical Vision, Inc.: FUSION Dual Pump Packs, REF: OPO73
- Recall number
- Z-1006-2023
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Product
- FUSION Dual Pump Packs, REF: OPO73
- Status
- Open, Classified
- Initiated
- 2022-12-07
- Posted
- 2023-01-20
- Terminated
- not on file
- 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
- Lot, serial or model codes
- UDI-DI/Lots: 15050474602080/60373238, 60394037, 60308197
- 510(k) numbers
- ["K160236"]
- PMA numbers
- not on file
- Product code
- HQC
- Firm FEI
- 3012236936
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28