Model Number 1MTEC30 |
Device Problem
Contamination (1120)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/30/2019 |
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 when using the platinum 1 series model 1mtec cartridge, it appeared there was material transferred from the cartridge onto the intraocular lens (iols).The surgeon was able to aspirate the material off the posterior side of the iol during the irrigation and aspiration segment.There was no consequence to the patient and the iol remains implanted.This report is 2 of 2 reports.
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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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Manufacturer Narrative
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Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 3/17/2020.Section h3: device returned to manufacturer? yes.Device evaluation: the returned complaint units were visually inspected the analysis revealed that no physical damage or significant visual flaws were observed.Based on the inspection performed, the complaint issue was not verified.However, the parts will be used for the continued investigation under a capa(b)(4).Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that one additional complaint was received from this lot number.Investigation was reviewed and is related to this complaint since is related to debris / particles code.Investigation was completed as no failure detected and referenced to capa (b)(4).Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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