Model Number EMERALDC30 |
Device Problem
Contamination (1120)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Sex/gender: unknown/ not provided.Date of event: unknown, not provided.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.The suspect cartridge will not be returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.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 an ar40e intraocular lens (iol) that was implanted by the doctor had a film on the edge that was visible when the doctor looked through the microscope after implantation.The doctor gently dislodged the film and removed it during aspiration.Through follow-up it was learnt that it¿s the doctor¿s opinion that the film came from cartridge.It was stated that the tech loaded the lens and the debris was in the cartridge but not visible at that point, however it was there when the lens was ejected.The lens remains implanted and that the patient has no visual issues.There is no plan to do any secondary surgical procedure.No other information was provided.
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Manufacturer Narrative
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Device evaluation: per initial report, the product will not be returned for evaluation.Therefore, the sample evaluation could not be performed.No cartridge pictures were provided.Although, only drawing from the lens box showing were the alleged debris were observed, the reported issue could not be verified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search on complaints revealed seven (7) additional investigations, for this manufacturing lot ce02380.The investigations revealed no product deficiencies.Conclusion: 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 (b)(4) and capa-010215.
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Search Alerts/Recalls
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