Model Number 1MTEC30 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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The cartridge is not an implantable device; therefore, not explanted.All pertinent information available to abbott medical optics has been submitted.
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Event Description
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It was reported that there were deposits on two intraocular lenses which may be visually significant.The customer suspects the problem is with the cartridge.This report is 1 of 2.No additional information was provided to abbott medical optics.
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Manufacturer Narrative
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Concomitant medical products: multifocal iols, serial number: unknown.All pertinent information available to abbott medical optics has been submitted.
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Manufacturer Narrative
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Device evaluation: the product was not returned for investigation.The reported complaint was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
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Search Alerts/Recalls
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