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Johnson & Johnson Surgical Vision Recalls HEALON EndoCoat PRO Over Insertion Instructions

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Johnson & Johnson Surgical Vision, Inc. is recalling 111,478 units of HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic devices worldwide due to surgical instructions provided for ophthalmic procedures.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on September 15, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "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.", distributed 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.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, Devices.

What Happened

Johnson & Johnson Surgical Vision, Inc. initiated a voluntary recall of certain HEALON viscoelastic products after surgical instructions were sent for use during ophthalmic viscosurgical cataract procedures. The instructions state that if resistance is encountered during insertion, the cannula should be withdrawn and insertion conditions reassessed before proceeding, as forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.

Which Products Are Affected

The recall covers 111,478 units distributed worldwide, including US nationwide distribution 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 products include:

  • HEALON EndoCoat PRO, REF: 10300012 (US/CAN), lots UA32232, UA32250, UA32268, UA32290, UA32292, UA32303, UA32371, UP31203, UP31205 (UDI-DI 5050474755093)
  • HEALON DUET PRO II, REF: 10300016 (US/CAN), lots UA32447, UA32448, UA32449, UB33008, UB33026, UB33082, UB33083, UB33175 (UDI-DI 5050474755116)
  • HEALON EndoCoat PRO, REF: 10301012 (EU), lots UB33014, UB33041, UB33057, UB33060, UB33100, UB33190 (UDI-DI 5050474755109)
  • HEALON DUET PRO II, REF: 10301016 (EU), lots UB33084, UB33194 (UDI-DI 5050474755123)

Recall number Z-3064-2026, Class II, initiated July 31, 2026.

What You Should Do

Follow the surgical instructions provided with the products regarding cannula insertion during procedures.

Why This Matters

The recall addresses instructions for viscoelastic products used in cataract procedures that note potential risks of corneal abrasion, iris trauma or descemet's membrane detachment if resistance is encountered.

Source

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts (Recall Z-3064-2026, FDA)

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Questions readers often have about this FDA recall.

What is this FDA recall about? ▾
Johnson & Johnson Surgical Vision, Inc. is recalling 111,478 units of HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic devices worldwide due to surgical instructions provided for ophthalmic procedures.
Which agency issued this alert? ▾
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter? ▾
The FDA classifies this as a Class II recall, citing "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." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected? ▾
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates? ▾
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.

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