Model Number CNA0T0 |
Device Problems
Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Edema (1791); Blurred Vision (2137)
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Event Date 03/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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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 health professional reported that following an intraocular lens (iol) implant procedure, at this stage it was unclear, whether patient presented with some oedema or reduced vision may be due to faulty iol.Additional information received and the surgeon states that, this particular lens was not faulty.The patient¿s vision is normal at one month post op.
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Manufacturer Narrative
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Correction provided in h.6.Additional information provided in h.3.And h.10.The product was not returned for analysis.The root cause for the reported complaint appears to be a coincidental event unrelated to product as it is stated in the file that the sales rep "heard back from the surgeon today and this particular clareon from the recalled batch was not faulty.The patients¿ vision is normal at 1 month post op." based on this information, the product did not cause/contribute to the event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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