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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:135846

Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

Official recall number

Z-1685-2015

Evidence summary

Product code
HJK
Recall status
Terminated
Event initiated
February 27, 2015
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1685-2015

Field note

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