ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR
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Model Number III |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2023 |
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 non-healthcare professional reported that during loading the plunger advanced past lens.There was no patient contact.
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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 the plunger advanced past lens, no patient contact; therefore, the condition 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.Because an injector 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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