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); Device Damaged by Another Device (2915)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for analysis.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 lens was damaged upon insertion by company inserter instrument that was defected.The iol was explanted during initial procedure.Clinical reason for explant was also mentioned as damaged lens using defected inserter.Additional information has been 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 damaged lens, defected company inserter and intraocular lens (iol) removal; 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.A sample was not received at the manufacturing site and no lot information was provided; therefore, 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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