Model Number PSCST30 |
Device Problem
Material Frayed (1262)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device.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 cartridge has a sharp edge on the tip.There was no patient contact.No additional information was provided to johnson & johnson surgical vision.
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Manufacturer Narrative
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Device available for evaluation? yes, returned to manufacturer on: 9/11/19.Device returned to manufacturer: yes.Device evaluation: the cartridge was observed with the tip deformed.The reported issue was verified but it could not be determined if the condition observed is related to manufacturing process as the reported device condition is consistent with a product that was handled and prepared for a surgical process.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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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