Model Number VICM5_12.1 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Code Available (3191)
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Event Date 09/06/2017 |
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 code available (secondary surgery, lens exchange) off-label use [anterior endothelium chamber depth < 3.0mm (2.96mm)] (b)(4).
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Event Description
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The reporter indicated the surgeon implanted a 12.1mm vicm5_12.1 implantable collamer lens, diopter -7.50 into the patient's right eye (od) on (b)(6) 2017.On (b)(6) 2017 the lens was exchanged for a longer lens due to low vault.The problem was resolved.
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Manufacturer Narrative
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Device evaluation: the lens was returned dry, in a micro centrifuge vial.There was clear surgical residue/debris on product.Visual inspection found no visible damage to the lens and foreign material on lens surface (clear residue on lens).(b)(4).
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Search Alerts/Recalls
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