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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:186001

EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.

Official recall number

Z-1352-2021

Evidence summary

Product code
LPL
Recall status
Terminated
Event initiated
February 16, 2021
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1352-2021

Field note

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