Device Problem
No Apparent Adverse Event (3189)
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Patient Problems
Dry Eye(s) (1814); Fatigue (1849); Headache (1880); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Product code: unk.(expiration date): unk, no serial number reported.(device manufacturing date): unk, no serial number reported.Claim #: (b)(4).
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Event Description
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(b)(6) complaint: the reporter indicated that the surgeon implanted an implantable collamer lens (icl) into the patients left eye (os).The patient reports "headaches due to dry eye, mgd." attempts to obtain additional information have not been successful.
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Manufacturer Narrative
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Claim#: (b)(4).
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Manufacturer Narrative
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Corrected data: h6 - health effect clinical code: 4581 - eyelid eczema, should have been included in initial medwatch report.Additional information: b5 - it was later reported by the patient that they also experienced "bad interaction with the head", fatigue (tiredness), discomfort and "pulling of the eye and face".Patient is seeking to have the lens removed.Lens remains implanted.H6 - health effect clinical code: 4581 - " bad interaction with the head", "pulling of the eye and face".Claim#: (b)(4).
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Manufacturer Narrative
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Claim#: (b)(4).
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Search Alerts/Recalls
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