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HEALON EndoCoat PRO and DUET PRO II
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MEDICAL DEVICE RECALLMODERATE

HEALON EndoCoat PRO and DUET PRO II

J&J Surgical Vision updates instructions for HEALON viscoelastic products used in cataract surgery over cannula insertion risks.

What to do

If you are a surgeon using HEALON EndoCoat PRO or HEALON DUET PRO II, review the updated surgical instructions. If resistance is encountered during cannula insertion, withdraw the cannula and reassess insertion conditions (angle, incision size, etc.) before proceeding.

Recalled
Listed
Updated
Agency
FDA
Firm
Johnson & Johnson Surgical Vision, Inc.
Recall ID
99496
Status
ONGOING

Why it was recalled

Johnson & Johnson Surgical Vision is updating surgical instructions for HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products used during ophthalmic viscosurgical cataract procedures. If resistance is encountered during cannula insertion, surgeons should withdraw the cannula and reassess insertion conditions before proceeding, as forcing it may cause corneal abrasion, iris trauma, or Descemet's membrane detachment.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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)

Lot code
10300012, UA32232, UA32250, UA32268, UA32290, UA32292, UA32303, UA32371, UP31203, UP31205
UDI-DI
5050474755093

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-09-01 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification