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)

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.

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 [email protected] 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.