Model Number TMICL12.6 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(device manufacturing date): unk, no serial number reported.(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).
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Event Description
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The reporter indicated that a 12.6mm, tmicl12.6, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2019 and explanted on (b)(6) 2019.Reason for explant is unknown.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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Event: updated to state: a 12.6mm tmicl12.6 implantable collamer lens of diopter -10.00/1.5/134 (sphere/cylinder/axis) was implanted into the patient's right eye (od).Work order search: no additional similar complaint type events within associated lots were found.Claim# (b)(4).
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Manufacturer Narrative
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Work order search not applicable in initial mdr.Claim#: (b)(4).
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Search Alerts/Recalls
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