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Model Number Z9002 |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted, give date: unknown, as the status of the lens was not provided.If explanted, give date: unknown, as the status of the lens was not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.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 the haptic of a z9002 14.0 diopter lens was bent upon advancement/when inserting into the eye.No additional information was provided.
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Manufacturer Narrative
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In review, of medwatch 2648035-2018-00855, it was determined the initial report was not an adverse event or product problem, however, was inadvertently sent.Therefore, an emdr is required to state that no further follow ups will be sent out under medwatch 2648035-2018-00855.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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