ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR
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Model Number III |
Device Problems
Device Damaged by Another Device (2915); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The product has not been returned to the manufacturing site.Root cause cannot be identified at this time.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A purchasing agent reported that during implantation of an intraocular lens (iol) the injector has a bent tip and scratched the lens.Additional information was requested.
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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 injector has a bent tip and scratched the lens; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Because a sample was not received and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, the root cause for customer complaint issue cannot be determined.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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