Model Number 1MTEC30 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.(b)(6).All pertinent information available to johnson and johnson surgical vision has been submitted.
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Event Description
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It was reported that the tip of the 1mtec30 cartridge was deformed.The issue was noted upon taking the cartridge out of the package and there was no patient contact reported.The procedure was completed successfully with the back up.There was no patient injury reported.No additional information was provided.
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Manufacturer Narrative
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Device available for evaluation: yes; returned to manufacturer on: 10/10/2019.Device returned to manufacturer: yes.Device evaluation: the product associated to the complaint was received.The cartridge was received on the tray packaged in a plastic bag.The tyvek lid was received as well.There are traces of viscoelastics at the cartridge tube indicating it was prepared for insertion.The cartridge tip is cracked and deformed.The damaged on the cartridge is compatible with damage that could be caused by a defective hand piece and/or wrong positioning of the cartridge.The reported issue was verified.Based on the product evaluation there is no indication of a product quality deficiency.Manufacturing records review: the manufacturing records were evaluated, and non- conformance reports (nc) were found associated to this production order number.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search in complaint system revealed that no other investigation request (irs) has been received for this lot.Conclusion: based on the investigation results, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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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