Model Number 1MTEC30 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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If implanted; give date: not applicable, the cartridge is not an implantable device.If explanted; give date: not applicable, the cartridge is not an implantable device.(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 was reported that the tip of platinum 1 series 1mtec30 cartridge was deformed, but lens was set and was implanted as is.The doctor felt the hardness when the lens passed through around the tip and the deformation of the cartridge tip worsened.It was also noted that there was no patient injury.No additional information provided.
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Manufacturer Narrative
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Device available for evaluation: yes, returned to manufacturer on: 03/25/2019.Device returned to manufacturer: yes.Device evaluation: the product was received in a plastic bag at the manufacturing site for evaluation.The 1mtec30 model was observed under microscope and scarce amount of viscoelastic were observed at the cartridge.The tip was observed 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 was handled and prepared for surgical procedure.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaint was received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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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