Model Number EMERALDC30 |
Device Problem
Material Protrusion/Extrusion (2979)
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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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Date of event: unknown, not provided, but the best estimate date is during 2018.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)(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 customer noticed a burr at the tip of emerald c30 cartridge, during the implantation of the intraocular lens (model unknown).Reportedly, the procedure was completed successfully with a back up cartridge.No patient injury was reported.No additional information was provided.The same issue was reported for two cartridges.This mdr is the first of 2 reports.
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Manufacturer Narrative
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Device available for evaluation? yes.Returned to manufacturer on: 12/13/2018.Device returned to manufacturer? yes.Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Residue of viscoelastic was observed on the cartridge indicating the device was prepared for use.The cartridge tip was observed deformed and the intraocular lens (iol) was stuck in the cartridge.The customer's reported complaint was verified.However due the condition of the sample returned, the complaint could not be related to the manufacturing process and it could be related to the handling process; therefore, a product quality deficiency was not identified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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.All pertinent information available to johnson and 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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