FDA-Device2026-09-09Class IIMISBRANDING

Johnson & Johnson HEALON EndoCoat PRO and HEALON DUET PRO II recalled for updated surgical instructions to prevent eye trauma

FALSE CLAIMSNationwide distributionMedical devices

What this means

Johnson & Johnson is sending updated surgical instructions for HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products used in cataract surgery. The new instructions emphasize that if resistance is felt when inserting the cannula, surgeons should stop, withdraw the cannula, and reassess insertion conditions rather than forcing it—to avoid potential injury to the cornea, iris, or Descemet's membrane (a delicate eye structure).

Review the updated surgical instructions before using these products in cataract procedures.
If you experience resistance during cannula insertion, withdraw and reassess insertion angle and incision size rather than forcing insertion.
Contact Johnson & Johnson Surgical Vision if you have questions about the updated guidance.

The agency's original wording

Hazard

Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide - US Nationwide distribution including in the states of PA, AL, AZ, AR, CA, FL, IL, IN, IA, KY, LA, ME, MI, MN, MS, NJ, NY, NC, OH, OR, TN, TX, WA, WV, HI, CO, MD, VA, WI, ID, NH, SD, OK, MA, NM, DE, GA, SC, CT, NV, MO, RI, KS, ND and the countries of CA, BE, CH, DE, DK, ES, FR GB, HU, IS, IT, NL, NO, PT, SE.

Affected count

111,478

Manufactured in

31 Technology Dr Ste 200, N/A, Irvine, CA, United States

Products

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)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3064-2026

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