The Recall Desk
HighFDA (Devices)·Z-3064-2026·Announced 2026-09-09

Johnson & Johnson Recalls HEALON Viscoelastic Products Due to Surgical Instructions

Johnson & Johnson is recalling HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products because surgical instructions may not adequately warn against forcing the cannula, which could cause eye injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where the hazard is a risk of harm (corneal abrasion, iris trauma, or Descemet's membrane detachment) due to insufficient warnings in the instructions, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Johnson & Johnson Surgical Vision, Inc. is recalling 111,478 units of HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products. These products are used during ophthalmic viscosurgical cataract procedures. The recall is due to the surgical instructions provided with the products. The instructions state that if resistance is encountered during insertion, the cannula should be withdrawn and insertion conditions reassessed before proceeding. The instructions warn that forcing the cannula may cause corneal abrasion, iris trauma, or Descemet's membrane detachment.

The affected products were distributed worldwide, including nationwide in the United States and in Canada, Belgium, Switzerland, Germany, Denmark, Spain, France, Great Britain, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden. Specific lot numbers and reference codes are listed in the agency's recall record.

Healthcare providers and patients should stop using the affected products and contact Johnson & Johnson Surgical Vision, Inc. for further instructions. Consumers should not attempt to use these products without professional guidance.

The recalled product

Product
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)
Manufacturer
Johnson & Johnson Surgical Vision, Inc.
Category
Medical Device — Ophthalmic Viscoelastic
Hazard
Affected units
111,478

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF/UDI-DI/Lot: 10300012/5050474755093/UA32232
  • UA32250
  • UA32268
  • UA32290
  • UA32292
  • UA32303
  • UA32371
  • UP31203
  • UP31205
  • 10300016/5050474755116/UA32447
  • UA32448
  • UA32449
  • UB33008
  • UB33026
  • UB33082
  • UB33083
  • UB33175
  • 10301012/5050474755109/UB33014
  • UB33041
  • UB33057

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Related recalls

Same manufacturer · Johnson & Johnson Surgical Vision, Inc.

See all →