HEALON DUET PRO II 10300016Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · HEALON DUET PRO II US · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jul 31, 2026Class IIOpen, Classified
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.
Z-3064-2026 · Root cause: Device Design · Recall details · FDA record ↗
Other AID, SURGICAL, VISCOELASTIC devices
- HEALON ENDOCOAT PRO 10300012Johnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC1 recall1 report
- HEALON ENDOCOAT VT585UJohnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC22 reports
- HEALON 5 10290051Johnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC20 reports
- HEALON GV PRO 10240014Johnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC15 reports
- Amvisc 59081LBausch & Lomb Incorporated · Aid, Surgical, Viscoelastic10 reports
- DUOVISC 8065183150Alcon Laboratories, Inc. · Aid, Surgical, Viscoelastic9 reports
- HEALON DUET PRO 10240016Johnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC9 reports
- Amvisc Plus 60081LBausch & Lomb Incorporated · Aid, Surgical, Viscoelastic7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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