Lower riskMedical device recall · FDA · Published December 7, 2022
Johnson & Johnson Surgical Vision FUSION Dual Pump Packs Recall: Risk of Surgical Delay
Johnson & Johnson Surgical Vision recalls FUSION Dual Pump Packs (REF: OPO73) due to potential surgical delays from pump failures. Affected units have specific UDI-DI/Lots numbers.
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.
Take action
Contact the company
📍Recalling firmJohnson & Johnson Surgical Vision, Inc.31 Technology Dr Ste 200 · Irvine, CA 92618-2302
“Johnson & Johnson Surgical Vision FUSION Dual Pump Packs Recall: Risk of Surgical Delay.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59197-johnson-johnson-surgical-vision-fusion-dual-pump-packs-recall-risk. Based on FDA recall #Z-1006-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1006-2023%22&limit=1).
The FDA announced on 2022-12-07 that Johnson & Johnson Surgical Vision, Inc. is recalling FUSION Dual Pump Packs due to a weld protrusion hazard. The defect may cause priming cycle failure during surgery, potentially leading to surgical delays and transient corneal edema.
How to tell if you have it
Brand: Johnson & Johnson Surgical Vision
Product: FUSION Dual Pump Packs
REF: OPO73
Lots: 60373238, 60394037, 60308197
The hazard
The recall involves a weld protrusion or physical gap between the housing and phaco pack cover that may exceed design specifications. This defect could lead to priming cycle failure and suboptimal vacuum delivery, resulting in surgical delay, longer surgical time, and transient corneal edema.
Context
GovInfoNow's records show Johnson & Johnson Surgical Vision, Inc. has 14 other recalls on record since 2018-05-09. Recent brand recalls include HEALON Products recalled on 2026-07-31 for corneal injury risk and Irrigation Sleeves recalled on 2024-03-14 for insufficient flow during eye surgery. Other recent recalls of similar products include Katalyst Surgical DEX Ophthalmic Tissue Forceps Recall (2026-03-25) and Vortex Surgical TID Pharos Illuminated Depressor Recall (2025-12-16).
How to tell if you have this one
Check the pump's serial number on the packaging or label. Affected units have UDI-DI/Lots numbers starting with 15050474602080 or 60373238.
Brand
Johnson & Johnson Surgical Vision
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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
Look for UDI-DI/Lots numbers starting with 15050474602080 or 60373238 on the pump packaging.
Where it went and when
Where it was distributed
Distributed in 8 states, and outside the U.S.
Listed by the agency
Not listed
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Illinois, Minnesota, Mississippi, New York, Ohio, Tennessee, Texas.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1006-2023 (December 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1006-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.