DeviceSignal · Recall classified
Johnson & Johnson Surgical Vision, Inc.
FDA classified a device recall on 2026-08-31 · Class II · Z-3064-2026
EventRecall classified
Effective2026-08-31
ClassificationClass II
On 2026-08-31 the FDA classified a device recall from Johnson & Johnson Surgical Vision, Inc. as Class II. Product: HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN)…. Recall Z-3064-2026. The firm initiated it on 2026-07-31. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3064-2026
- Classification
- Class II
- Classified on
- 2026-08-31
- Initiated on
- 2026-07-31
- Firm
- Johnson & Johnson Surgical Vision, Inc.
- 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.
- 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)
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3064-2026- Snapshot hash
2ad9ab6cbee6c5eb2f0d4298731a8c9755893d917528d78bf00a015fa69a0494- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-15T12:38:10.708Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
9a4a2a9da67093061405d829aeaffaa110f2eba87598742efec7be5b80596935- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)