Class II device recall: Johnson & Johnson Surgical Vision, Inc. — HEALON EndoCoat PRO
Why it matters
Instruction-related recall on an ophthalmic viscoelastic is a labeling correction with low materiality.
Details
Johnson & Johnson Surgical Vision, Inc. recalled 1 device product (Class II) reported 20260909: HEALON EndoCoat PRO. 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 . Source: openFDA enforcement reports.
Sources
- openfda · fda.gov · 2026-09-09 12:00 UTC