Model Number VTICMO12.6 |
Device Problems
Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Blurred Vision (2137); No Code Available (3191)
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Event Date 05/18/2016 |
Event Type
Injury
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Manufacturer Narrative
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The product is manufactured in the us, but not marketed in the us.No similar complaint type events 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 12.6mm vticmo12.6 implantable collamer lens, -12.5/+3.5/094 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2016.The surgeon reports low vault and refractive change over time.Reportedly, the lens remains implanted.The cause of the event is reported as unknown.
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Manufacturer Narrative
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H3 - device evaluation: lens was returned in a case/vial and dry.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specifications.Additional information: b5 - it was reported that on (b)(6) 2020 the lens was exchanged with a longer length lens and the problem was resolved.H6 - patient code 3191: no code available (secondary surgery, lens exchange).Claim#: (b)(4).
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Manufacturer Narrative
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Corrected data: g4 - (b)(6) 2020 should be corrected to (b)(6) 2020 in supplemental #1 medwatch report.Claim#: (b)(4).
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Search Alerts/Recalls
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