Model Number VICM5 12.6 |
Device Problems
Material Opacification (1426); No Apparent Adverse Event (3189)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Weight: unk.Ethnicity unk.Race: unk.Date of event: 2019.Implanted: 2019.This product is not marketed in the us.Work order search: one 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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Event Description
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The reporter indicated that the surgeon implanted a 12.6mm vicm5 12.6, -04.50 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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Manufacturer Narrative
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Device code 3189 is not applicable in initial mdr.Device code 1426 should have been reported in initial mdr.Claim#: (b)(4).
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Manufacturer Narrative
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Diopter corrected to -4.0 in initial mdr.Result code 213 corrected to result code 114 in initial mdr.(b)(4).
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Search Alerts/Recalls
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