Z-2247-2023Class II

VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)

Name: Z-2247-2023 VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Creator: Johnson & Johnson Surgical Vision, Inc.
Published: 2023-05-30
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2023-05-30 / Open, Classified / root cause: manufacturing process

FDA source

Johnson & Johnson Surgical Vision, Inc. began a recall of VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF) on 2023-05-30. FDA classified it as Class II and gives the reason as "Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2247-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-30
Posted: 2023-07-28
Recalling firm: Advanced Medical Optics, Inc.
Product: VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Product code: HQC Unit, Phacofragmentation
Reason for recall: Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 5/30/23, recall notices were mailed to customers who were asked to do the following: 1) Discontinue use and return affected devices to the recalling firm. 2) Share this notice with anyone within your organization that needs to be informed and to any organization where the potentially affected products have been transferred. 3) Complete and return the customer reply form to [email protected] In addition, distributors were asked to distribute the recall notice to their customers. Questions, adverse events, and complaints can be directed to the firm at 1-877-266-4543 Option 2.
Quantity in commerce: 148,941
Distribution: Worldwide - US Nationwide distribution including in the states of NC, OH, NY, IN, FL, TN, CA, PA, AZ, AL, TX, WA, WV, MS, GA, UT, KY, IA, MO, AR, DE, IL, WI, VA, NJ, LA, SC, HI, OR, VT, MN, NV, CO and the countries of Argentina, Australia, Austria, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Korea¿(South), Kuwait, Lebanon, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela.
Product codes and lots: All lots within their expiration date as of 5/29/2023. Part Number/UDI-DI/Lot: VRT-AI/05050474700901/60298931, 60302489, 60302939, 60302941, 60302953, 60302954, 60304170, 60304175, 60304176, 60305660, 60305661, 60305662, 60305665, 60306934, 60306935, 60306936, 60306940, 60306942, 60308193, 60309850, 60309844, 60309845, 60309853, 60314642, 60314676, 60314677, 60316112, 60351692, 60372490, 60372491, 60374175, 60374945, 60376930, 60378840, 60378842, 60378844, 60400795, 60401984, 60413115, 60413116, 60413117, 60414191, 60415077, 60415078, 60416304, 60420003, 60421952, 60425389, 60426314, 60426315, 60428217, 60428216, 60429442, 60433653, 60433654, 60433655, 60435921, 60435922, 60435923, 60437988, 60437989, 60440239, 60440240, 60442450, 60442451, 60442452, 60442453, 60442454, 60444535, 60446059, 60448847, 60448856, 60448857, 60376931, 60379976, 60429443. VRT-AF/05050474700895/60304172, 60304173, 60304174, 60305657, 60305658, 60305659, 60306930, 60306931, 60306932, 60306933, 60308189, 60308190, 60309848, 60309847, 60314640, 60314641, 60314674, 60314675, 60378839, 60420004, 60446054, 60446055

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2247-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2247-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28

Product code HQC

K203060Class IIVERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote ControlJohnson & Johnson Surgical Vision, Inc. / cleared 2021-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)