Device evidence

device-recall:cfres:165749

ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

Official recall number

Z-0011-2019

Evidence summary

Product code: HMX
Recall status: Terminated
Event initiated: January 11, 2018
Root cause: Process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0011-2019