Class 2 Device Recall HEALON EndoCoat" PRO Ophthalmic Viscosurgical Device (OVD) and HEALON DUET PRO II Dual Pack

• Date Initiated by Firm: July 31, 2026
• Date Posted: August 31, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3064-2026
• Recall Event ID: 99496
• PMA Number: P810031S078
• Product Classification: Aid, surgical, viscoelastic - Product Code LZP
• 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)
• Code Information: 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
• FEI Number: 3012236936
• Recalling Firm/ Manufacturer: Johnson & Johnson Surgical Vision, Inc.; 31 Technology Dr Ste 200; Irvine CA 92618-2302
• For Additional Information Contact: Global Post Market Safety; 877-266-4543
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LZP