Model Number 1MTEC30 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Code Available (3191)
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Event Date 07/23/2018 |
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.(b)(4).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 1mtec30 un-folder cartridge split open upon injecting the lens inside the patient's eye.As a result, the surgeon decided to abort the process and replace it with other lens.Furthermore, the customer confirmed that the split was at the cartridge tip per follow-up.It was noted also that incision has been enlarged prior to inserting the lens.However, there were no suture, no vitrectomy and no apparent patient injury reported at that time.No additional information provided.
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Manufacturer Narrative
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Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search in the complaint system was performed on september 19, 2018 revealed an additional investigation request for this production order number with a reported device problem code of cartridge damaged.The investigation is closed, no product deficiency was determined.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.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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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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