ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)
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Model Number IV |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/03/2023 |
Event Type
malfunction
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Event Description
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A facility representative reported that during an intraocular lens (iol) implant procedure, it was noted that the root of the haptic was scratched by the injector.The optical part was off from center, and the doctor said there was no problem, so the surgery was completed as it was.There was a possibility that the scratches were caused by incorrect setting.Additional information has been requested.
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation for the report of root of haptic was scratched, optic was off center; therefore, the condition of the product could not be verified.A photo attached to the parent complaint was reviewed by the investigation site.The details of the photo and what is shown in the photo are unclear.Therefore, the reported complaint cannot be confirmed from the photo.The root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).
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