ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; LENS, GUIDE, INTRAOCULAR
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Model Number ASKU |
Device Problem
Positioning Problem (3009)
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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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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 that during an intraocular lens (iol) implant procedure, the injector went over the cartridge while attempting to insert the iol.There was no harm to the patient.Additional information received states that a new iol, cartridge, and injector were used to complete the procedure on the same day.
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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 went over the cartridge; therefore, the condition of the product could not be verified.Even though no lot number was identified with this complaint; our products are processed and released according to the product¿s acceptance criteria.Because an injector sample was not received at the manufacturing site and no lot information was provided, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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