Model Number 1CART30 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted, if explanted, give date: not applicable, the cartridge is not an implantable device.Email address: unknown/not provided.Attempts have been made to obtain missing information; however, no definitive 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 there were 3 cartridges that appeared to have a sharp/warped, and melted tips, upon attempted implantation, the leading haptic broke/sheared off by the cartridge.There was no patient contact.No additional information provided.This report is for #3 of the 3 reported events.A separate report is being submitted for each of the 3 cartridges.
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Manufacturer Narrative
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Device evaluation: product testing could not be performed because the product was not returned.The reported complaint was not confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.
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Manufacturer Narrative
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Upon further review it was noted that the initial mdr had the incorrect aware date of 6/25/19.Therefore, this supplemental filing is to correct the aware date to 6/26/19.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 (b)(4) and capa-010215.
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Search Alerts/Recalls
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