CLASS II ONGOING Device recall · Reported 1 Feb 2023 · FDA Enforcement Report
Single-Use Packs recalled by Johnson & Johnson Surgical
Johnson & Johnson Surgical Vision is recalling Single-Use Packs, distributed in 8 states. The recall was initiated on 7 Dec 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1007-2023
- FDA event ID
- 91290
- Recalling firm
- Johnson & Johnson Surgical Vision, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Dec 2022
- FDA classified
- 20 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 7 Dec 2022 | Recall initiated by company | |
| 20 Jan 2023 | Classified by FDA | +44 days |
| 1 Feb 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Single-Use Packs, REF: OPO80
Where it was distributed
US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, United Kingdom
FloridaIllinoisMinnesotaMississippiNew YorkOhioTennesseeTexas
Questions about this recall
Why was it recalled?
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Which lots are affected?
UDI-DI/Lot: 05050474573352/60326033
Where was it sold?
US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 91290This product is part of a recall event; the main page for the event is Fusion Dual Pump Packs recalled by Johnson & Johnson Surgical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Fusion Dual Pump Packs recalled by Johnson & Johnson Surgical | Johnson & Johnson Surgical Vision | Device Malfunction | 8 states | |
| CLASS II | Veritas Advanced Infusion Packs recalled by Johnson & Johnson Surgical | Johnson & Johnson Surgical Vision | Device Malfunction | 8 states |
More recalls from Johnson & Johnson Surgical Vision
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|---|---|---|---|---|---|
| Device | CLASS II | Healon EndoCoat PRO recalled by Johnson & Johnson Surgical | Johnson & Johnson Surgical Vision | Other | Nationwide |
| Device | CLASS II | Johnson & Johnson Vision Reusable Laminar High Flow recalled | Johnson & Johnson Surgical Vision | Other | Nationwide |
| Device | CLASS II | Tecnis Toric II OptiBlue IOL recalled by Johnson & Johnson Surgical | Johnson & Johnson Surgical Vision | Potency & Assay | CA |
| Device | CLASS II | Tecnis Eyhance IOL recalled by Johnson & Johnson Surgical | Johnson & Johnson Surgical Vision | Other | CA |
| Device | CLASS II | Tecnis Symfony, Extended Range of Vision IOL recalled | Johnson & Johnson Surgical Vision | Other | CA |
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| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |