Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Reported: October 19, 2022 Initiated: September 1, 2022 #Z-0086-2023
Product Description
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
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.
Details
- Recalling Firm
- Johnson & Johnson Surgical Vision, Inc.
- Units Affected
- 53,624 units
- 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
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.. Recalled by Johnson & Johnson Surgical Vision, Inc.. Units affected: 53,624 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2022. Severity: Moderate. Recall number: Z-0086-2023.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11