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it is not required to report to china nmpa since it is considered as not-serious.

hongyan zou 17-dec-2021"

"consumer complained from email: hello, i bought the following


products at the optical store on 12/19. i felt abnormal when i wore it on
12/22 in the morning, but thought it was the first time i was not used to
wearing it. but at noon, my eyes were getting more and more painful
and i found there is a small piece of lens in my eye... the one that is
broken is with power 0, and power 3.00 is not broken. it caused the eye
to be red, swollen and painful now, please focus more on quality
control. this case is not reportable in taiwan. marina wang 24-dec-2021"

"this is an authority feedback case via the china national medical device
adverse events reporting system. this event was reported to china
national medical device adverse events reporting system by shanghai
qingpu bailian oriental commercial building co., ltd. injury manifestation:
eye discomfort. device failure manifestation: biocompatibility issues.
description of application: the customer bought a box of product (- 3.25)
for vision correction. the next day, the patient complained of eye
discomfort, foreign body sensation and eye discomfort after wearing the
lens. the discomfort symptoms disappeared after removing the contact
lens. event cause analysis: can't be determined. event cause analysis
description: contact lenses may be less compatible with customer.
preliminary measure(s) for handling the situation: the customer did not
feel eye discomfort after replacing other brand product with the same

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