CLASS II ONGOING Device recall · Reported 19 Oct 2022 · FDA Enforcement Report

Veritas Advanced Infusion Packs recalled by Johnson & Johnson Surgical

Johnson & Johnson Surgical Vision is recalling Veritas Advanced Infusion Packs, distributed in 24 states. The recall was initiated on 1 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: VRT-AI UDI-DI Code: 05050474700901 Lot Numbers: 60316112 60330206 60330248 60341105 60341106 60341107 60342401 60343412 60343413 60351691 60352993 60352994 60352995 60352996 60352997 60352998 60352999 60353436 60353443 60353444 60353445 60353446 60353447 60353448 60353449 60353450 60353451 60353452 60353453 60353772 60353811 60353812 60353813 60353814 60353815 60354982 60355023 60355024 60355025 60355026 60355027 60355330 60355335 60355972 60360065 60360066 60362043 60362044 60362435 60362436 60364566 60369607 60369608 60369609 60381689

Quantity recalled53,624 units

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-0086-2023
FDA event ID: 90847
Recalling firm: Johnson & Johnson Surgical Vision, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 1 Sep 2022
FDA classified: 12 Oct 2022
Reported: 19 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

1 Sep 2022	Recall initiated by company
12 Oct 2022	Classified by FDA	+41 days
19 Oct 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

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

Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

Where it was distributed

Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL IN, KY LA, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, VA, and WA; Australia, Azerbaijan, Belgium, Brazil, Canada, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan, Jordan, Kuwait, Morocco, Netherlands, New Zealand, Oman, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom

Alabama Arkansas Arizona California Colorado Delaware Florida Georgia Hawaii Illinois Kentucky Louisiana Minnesota Missouri Mississippi North Carolina New Jersey New York Ohio Tennessee

Questions about this recall

Why was it recalled?

As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

Which lots are affected?

Part Number: VRT-AI UDI-DI Code: 05050474700901 Lot Numbers: 60316112 60330206 60330248 60341105 60341106 60341107 60342401 60343412 60343413 60351691 60352993 60352994 60352995 60352996 60352997 60352998 60352999 60353436 60353443 60353444 60353445 60353446 60353447 60353448 60353449 60353450 60353451 60353452 60353453 60353772 60353811 60353812 60353813 60353814 60353815 60354982 60355023 60355024 60355025 60355026 60355027 60355330 60355335 60355972 60360065 60360066 60362043 60362044 60362435 60362436 60364566 60369607 60369608 60369609 60381689

Where was it sold?

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.

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