Model Number ZMA00 |
Device Problems
Bent (1059); Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2012 and (b)(6) 2018.(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 zma00 26.0 diopter intraocular lens (iol) was implanted in the patient's operative eye on (b)(6) 2012.It was later explanted on (b)(6) 2018 because the haptic of the lens was noticed distorted, which caused the lens to not stay centered properly.There was an incision enlargement performed and 3 sutures were used.There was no vitrectomy performed.The lens was not replaced and the patient went home aphakic.Reportedly, there was no patient injury and the patient is doing fine post-operatively.In addition, it was reported that the patient has retina related issues that are not related to the product.No additional information was provided.
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Manufacturer Narrative
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Device available for evaluation: yes.Returned to manufacturer on: 03/21/2018.Device returned to manufacturer: yes.The product was returned to the manufacturing site for evaluation.Visual inspection at 12x microscope magnification showed there were no anomalies.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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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Search Alerts/Recalls
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