Model Number 1MTEC30 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted; give date: not applicable, as the cartridge is not an implantable device.If explanted; give date: not applicable, as the cartridge is not an implantable device; therefore, not explanted.Phone: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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It has been reported issues with 2 units of 1mtec30.When operating room (or) staff opened 1mtec30 cartridge case, they noticed emeraldc30 cartridge inside.Noticed when removing from packaging.No patient involvement reported.No further information has been provided to johnson & johnson vision.This is report two of two.
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Manufacturer Narrative
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Manufacturing record evaluation: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search revealed, that no additional complaints for this order number have been received.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, inc.Has been submitted.
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Manufacturer Narrative
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Additional information: section d10: device available for evaluation: yes.Date returned to manufacturer: 8 feb, 2021.Section h3: device returned to manufacturer: yes.Device evaluation: complaint product was returned in a plastic bag.One opened cartridge was received labeled as 1mtec30 cartridge model with lot number ce10130, and one emerald cartridge model was inside the tray.The reported issue was verified.Based on the investigation there is an indication of a potential product malfunction and product deficiency.Johnson & johnson surgical vision has initiated a corrective and preventative action (capa- 010465) to investigate and address the issue.Johnson and johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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