Model Number ZCB00 |
Device Problem
Bent (1059)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted, give date: not applicable no patient contact reported.If explanted, give date: not applicable no patient contact reported.All pertinent information available to abbott medical optics has been submitted.
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Event Description
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It was reported that there was a bend in an intraocular lens (iol) upon opening the lens case.No patient contact was reported.The lens was discarded by the customer.No further information was provided.
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Manufacturer Narrative
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Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.As a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.
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Search Alerts/Recalls
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