Johnson & Johnson Surgical Vision, Inc. recalls VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advance

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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