ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; LENS, GUIDE, INTRAOCULAR
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Model Number ASKU |
Device Problems
Defective Device (2588); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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 facility representative reported during an intraocular lens (iol) loading procedure, inserter broken and went over the lens and there was no patient contact.
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Manufacturer Narrative
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Additional information was provided in h.3., h.6.And h.10.A sample was not received at the manufacturing site for evaluation for the report of an intraocular lens (iol) jammed into injector and inserter broken went over lens; therefore, the conditions of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).
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