Model Number VICM5_13.7 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problems
Blurred Vision (2137); Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
malfunction
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Manufacturer Narrative
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Pt info: unk.Health impact- clinical code: 4581 - positive dysphotopsia.Work order search: another similar complaint was reported for units within the same lot.Claim # (b)(4).
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Event Description
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The reporter indicated the surgeon implanted a 13.7mm vicm5_13.7 implantable collamer lens, -13.00 diopter, into the patients left eye (os) on (b)(6) 2022.The patient reported has developed positive dysphotopsia and the lens remained implanted.Additional information has been requested but none has been forthcoming.
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Manufacturer Narrative
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Corrected data: b5: the patient experienced "positive dysphotopsia" (glares/ haloes).Claim#: (b)(4).
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Search Alerts/Recalls
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