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Model Number EMERALDC30 |
Device Problems
Crack (1135); Device Damaged by Another Device (2915)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, give date: not applicable as this is not an implantable device.¿ if explanted, give date: not applicable as this is not an implantable device.¿ phone: (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 emeraldc30 injectors presented a quality deviation, probably a defect with the injectors.Once it has cracked during the mounting of the intraocular lens (iol).The same problem has occurred during several surgeries, and in one of them, one iol was lost (sensar ar40e +26.5 diopter).There was a need to use a second lens to continue with the procedure and avoid patient injury.The product was within the manufacturing expiration date and passed the hospital's standardization committee.The device was within the sterilization deadline, and the manufacturer's maintenance recommendations were followed.Additional information was received stating that there was patient contact with the reported cartridges, but there was no patient injury.No further information provided.
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Manufacturer Narrative
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Device evaluation: the product was not returned, the complaint issue reported could not be verified.Product deficiency could not be determined.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search revealed one additional complaint folder for this production order number for device code dc-cartridge tip cracked/damaged.Product deficiency not identified.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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Search Alerts/Recalls
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