Johnson & Johnson Surgical Vision, Inc.: 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)

Recall number

Z-3064-2026

Recalling firm

Johnson & Johnson Surgical Vision, Inc.

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)

Status

Open, Classified

Initiated

2026-07-31

Posted

2026-08-31

Terminated

not on file

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.

Root cause

Device Design

Action

On 7/31/2026, correction notices were mailed to customers and distributors informing them of the following: Device Insertion Technique Clarification: If resistance is encountered during insertion, withdraw the cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding. Do not force the cannula through the incision, as this may increase the risk of unintended tissue injury, including, but not limited to corneal abrasion, iris trauma or Descemet s Membrane Detachment, which may require medical or surgical intervention to preclude serious injury. This investigation is currently ongoing, and we will notify users if any additional information comes to light. 1) Forward this notice to all surgeons using this device in your facility. 2) If any of the subject product has been transported to another facility/surgeon, contact that facility/surgeon and provide/forward this notice to them. 3) Keep a copy of this notice with the subject product. 4) Complete, sign, and return the Business Reply Form via email to RegCompliOne@its.jnj.com If you have questions or concerns with regard to this notification, please contact the firm's Global Post Market Safety Team at 1-877-266-4543, Option 2. Additional notices with additional affected devices to be sent in the future.

Quantity

111,478

Distribution

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.

Lot, serial or model codes

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, UB33060, UB33100, UB33190; 10301016/5050474755123/UB33084, UB33194

510(k) numbers

not on file

PMA numbers

["P810031S078"]

Product code

LZP

Firm FEI

3012236936

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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