Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Summary
The FDA issued a Class II for Veritas Advanced Infusion Packs. Used in ophthalmic procedures. by Johnson & Johnson Surgical Vision, Inc.. Reason: As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue..
Details
Source
Device Recall
External ID
Z-0086-2023
Action Date
2022-10-19
Status
Ongoing
Category
device
Product Description
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Lot/Code Info: 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
Quantity Affected: 53,624 units
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.
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-01
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Johnson & Johnson Surgical Vision, Inc. has 13 FDA actions in our database, including 12 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Johnson & Johnson Surgical Vision, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Johnson & Johnson Surgical Vision, Inc. have FDA actions?
Johnson & Johnson Surgical Vision, Inc. has 13 FDA actions in our database, including 12 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0086-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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