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Model Number 1MTEC30 |
Device Problems
Difficult or Delayed Positioning (1157); Positioning Failure (1158); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/23/2018 |
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.Attempts have been made to obtain missing information; however, to date, no response has been received.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 zcb00 intraocular lens (iol) did not glide out of the shooter due to a loading error.The surgeon switched to another lens (same model) and a new cartridge.There was patient contact with the lens, however it was confirmed that there was no patient injury, no incision enlargement, no suture used.No further information was provided.
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Manufacturer Narrative
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Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search 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 for the proper use and handling of the product.Conclusion: based on the investigation results, 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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Search Alerts/Recalls
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