Model Number 1MTEC30 |
Device Problem
Failure to Eject (4010)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Age/date of birth: unknown/not provided.Sex/gender: unknown/not provided.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 while the doctor was attempting to insert the intraocular lens (iol) into the patient eye, the iol became stuck in the platinum cartridge, model 1mtec30.It was indicated that the lens was partially delivered and that it contacted the patient's eye.The doctor removed all instruments from the eye and proceeded with another lens of the same model/diopter as a replacement.It was confirmed that there were no surgical interventions required.The surgery was a success and there was no patient injury reported.No additional information was provided.
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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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Section d10.Device available for evaluation? yes; returned to manufacturer on: 03/10/2020 section h3.Device returned to manufacturer? yes.Device evaluation: the device was returned to manufacturing site for evaluation.The sample was evaluated, and the cartridge was observed with residues of viscoelastic.No damage was observed.Due to the condition in which the cartridge returned, the reported issue could not be verified.As the cartridge returned was handled, a product quality deficiency or product malfunction could not be determined.The complaint issue could not be verified to be associated to manufacturing process.Manufacturing records review: the manufacturing records for the device were reviewed.There was no discrepancy found during the mrr (manufacturing record review).There were no non-conformance reports (nc) found associated to this production order number.The product was manufactured and released according to specification.A search in complaint system revealed one (1) other complaint folder has been received for this production order number; however, no product quality deficiency was identified in that case.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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