Model Number ZXR00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Blurred Vision (2137); No Code Available (3191)
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Event Date 10/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that a zxr00 intraocular lens (iol) was explanted due to blurry vision, described as difficulty seeing street signs with shadowing on peripheral vision.The patient's pre-op visual acuity was 20/40.Follow-up confirmed that the patient had visual acuity of 20/20 post-op day one.The replacement lens model was zcb00 26.5 diopter power.No other information was received.
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Manufacturer Narrative
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Device available for evaluation? yes, returned to manufacturer on: 9/19/2019.Device returned to manufacturer? yes.Device evaluation: the return sample was received.The product was received in a lens case.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no similar complaints were received from this production order.Conclusion: 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 johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.
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Search Alerts/Recalls
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