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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:141530

IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.

Official recall number

Z-0357-2016

Evidence summary

Product code
HJO
Recall status
Terminated
Event initiated
October 27, 2015
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0357-2016

Field note

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