Weight: unk.Ethnicity: unk.Race: unk.Date of event: 2019.Implanted: 2019.This product is not marketed in the us.Work order search: no similar complaint type events were reported for units within the same lot.Device history record (dhr) review; based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(b)(4).
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The reporter indicated that the surgeon implanted a 12.6mm vicm5 12.6, -11.50 diopter, implantable collamer lens into the patient's eye in 2019.White accretion on the lens and lens opacity were observed.The lens remains implanted.Cause of the event is reported as device.Reportedly there is a possibility the lens may be explanted in the future.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
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