The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam became degraded and caused eye issues, lazy eye, itchy/watery/painful eyes and worsening vision.The patient did report to receive medical intervention and saw an optician, prescribed glasses and eye drops.The patient reported this to the fda on vmw #mw5112849.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: the manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged to experience eye issues, lazy eye, itchy/watery/painful eyes and worsening vision.The patient did report to receive medical intervention and saw an optician, prescribed glasses and eye drops.The reported events of eye issues, lazy eye, itchy/watery/painful eyes and worsening vision and its reported severity was reviewed by the manufacture's clinical expert.These events are assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.The device has not yet returned to the manufacturer for evaluation and at this time, no further investigation can be performed.Ifany additional information is received, a follow up report will be filed.Sections b1, b2 has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.
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