Model Number VTICMO13.2 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Headache (1880); Pain (1994); No Code Available (3191)
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Event Date 11/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Work order search: no similar complaint was reported for units within the same lot.(b)(4).
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Event Description
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The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -4.00/+4.0/033 (sphere/cylinder/axis) in the patient's left eye (os), on (b)(6) 2018.The reporter indicated the lens had excessive vaulting and the patient experienced severe headache.The reporter indicated the related symptom may be due to shallow anterior chamber (mid peripheral iridocorneal touch in turn causing headache and eye pain).The lens remains implanted.The reporter stated the cause of the event is the device.
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Manufacturer Narrative
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The reporter indicated the lens was explanted on (b)(6) 2018.The lens was exchanged for a shorter lens and the problem was resolved.(b)(4).
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Manufacturer Narrative
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The exchange lens did not resolve the issue.Reference mfr report # 2023826-2019-00435 for further details on the exchange lens.Common device name should be corrected to phakic toric intraocular lens in original mdr.Claim#: (b)(4).
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Manufacturer Narrative
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Additional data device evaluation- the lens was returned dry in a microcentrifuge vial.Visual inspection found blue residue on lens surface and no visible damage to the lens.Claim# (b)(4).
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Search Alerts/Recalls
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