Model Number CNA0T0 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Visual Impairment (2138); Fibrosis (3167)
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Event Type
Injury
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Manufacturer Narrative
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A sample device was not returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported following the intraocular lens implantation the patient had experienced white biological deposit on the lens, lecog like with variable intensity, sometime requiring a yag anterior capsulotomy.Additional information has been requested.
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Manufacturer Narrative
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The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The product was not returned for analysis.Only five photos were returned.Photos 3, 4 and 5 appear to be of the same eye under various magnifications.A cellular deposit, possibly fibrotic in nature, is present on the anterior surface of the lens expanding inward from the periphery and joining to form a bridge across the pupillary zone.Photos 1 and 2 appear to be of the same eye (unknown if the same as in images 3-5) possibly showing the eye post-yag demonstrating a retraction of the cellular material as conveyed in the follow up information provided.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information has been received and stated that, the eye that had a deposit in the pupillary axis is doing really well since its yag (yttrium aluminum garnet) laser.Post operation with reduced visual acuity ad 20/50 and after yag there is no more deposit and patients vision is back to 20/20.The symptoms were resolved to the patient.
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Search Alerts/Recalls
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