WHITESTAR SIGNATURE recallZ-1006-2023 · Johnson & Johnson Surgical Vision, Inc. · initiated Dec 7, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Johnson & Johnson Surgical Vision, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1006-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 7, 2022
- Posted by the FDA
- Jan 20, 2023
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Quantity
- 7644
- Product code
- HQC
- FDA submissions
- K160236
- 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
Product description
FUSION Dual Pump Packs, REF: OPO73
Code information (models, lots, serial numbers)
UDI-DI/Lots: 15050474602080/60373238, 60394037, 60308197
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- WHITESTAR SIGNATURE OPO73Johnson & Johnson Surgical Vision, Inc. · Unit, phacofragmentation1 recall43 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 91290).
- Z-1005-2023 · Open, ClassifiedVeritas Advanced Infusion Packs, REF: VRT-AI
- Z-1007-2023 · Open, ClassifiedSingle-Use Packs, REF: OPO80
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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