Recall Z-2247-2023
Johnson & Johnson Surgical Vision, Inc. · initiated May 30, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Codes / 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
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.
FDA-determined cause: Process control
Action taken
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 RegCompliOne@its.jnj.com 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.
Details
- Recall number
- Z-2247-2023
- Initiated
- May 30, 2023
- Posted by FDA
- July 28, 2023
- Product code
- HQC – Unit, Phacofragmentation
- Quantity
- 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…
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc., Irvine, CA