FDA recall, , Moderate risk
Johnson & Johnson HEALON EndoCoat PRO and HEALON DUET PRO II
Viscoelastic products used in cataract procedures may cause corneal abrasion, iris trauma, or descemet's membrane detachment if forced.
Summary by Recall Canary from the FDA notice
What happened
Johnson & Johnson Surgical Vision, Inc., of Irvine, California, began a recall of HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products on July 31, 2026, because surgical instructions state that forcing the cannula during insertion may cause corneal abrasion, iris trauma or descemet's membrane detachment. The FDA added the recall to its Enforcement Report on August 31, 2026, with nationwide distribution in the U.S. and worldwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your can affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Healon EndoCoat Pro, REF: 10300012 (US/CAN) Healon Duet Pro II, REF: 10300016 (US/CAN) Healon EndoCoat Pro, REF: 10301012 (EU); Healon Duet Pro II, REF: 10301016 (EU)
- UDI-DI
- 10300012
- 5050474755093
- 10300016
- 5050474755116
- 10301012
- 5050474755109
- 10301016
- 5050474755123
- Lot code
- UA32232
- UA32250
- UA32268
- UA32290
- UA32292
- UA32303
- UA32371
- UP31203
- UP31205
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Pennsylvania, Alabama, Arizona, Arkansas, California, Florida, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Michigan, Minnesota, Mississippi, New Jersey, New York, North Carolina, Ohio, Oregon, Tennessee, Texas, Washington, West Virginia, Hawaii, Colorado, Maryland, Virginia, Wisconsin, Idaho, New Hampshire, South Dakota, Oklahoma, Massachusetts, New Mexico, Delaware, Georgia, South Carolina, Connecticut, Nevada, Missouri, Rhode Island, Kansas, North Dakota and the countries of California, BE, CH, Delaware, DK, ES, FR GB, HU, IS, IT, NL, NO, PT, SE.
- Company
- Johnson & Johnson Surgical Vision, Inc.Irvine, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99496
- Recall number
- Z-3064-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
