Z-2247-2023 Class II Ongoing
Recalled by Johnson & Johnson Surgical Vision, Inc.
— Irvine, CA
FDA device recall Z-2247-2023 was initiated by Johnson & Johnson Surgical Vision, Inc. on May 30, 2023 and is designated Class II. 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 deliv… The recall status is ongoing. Affected quantity: 148,941.
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- May 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 148,941
Product Description
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
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.
Distribution Pattern
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.
Code Information
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