Model Number 1MTEC30 |
Device Problem
Break (1069)
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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: 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; therefore, not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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The surgery center reported of an issue with the 1mtec30 unfolder cartridge.When inserting the lens, a small piece of the distal plastic tip of the cartridge went into the patient's eye.The surgeon was able to remove the plastic from the eye and there was no patient injury reported.No additional information provided.
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Manufacturer Narrative
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Device evaluation: the product was received; however, it was inadvertently scrapped and is not available.Since product is not available, the complaint issue reported could not be verified.Product deficiency could not be determined.Manufacturing records review: the manufacturing records for the product was reviewed.There are no discrepancies found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search in complaints history performed in april 30, 2019 revealed that only one additional investigation request for this production order number.The investigation did not identify any product deficiency.Labeling review: the directions for use (dfu) were 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 (b)(4) and capa-010215.
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Search Alerts/Recalls
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