ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)
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Model Number IV |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2023 |
Event Type
malfunction
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Event Description
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A facility representative reported that during an intraocular lens (iol) implant procedure, the lens loaded normally without issue, but when delivered into the eye, the haptic was noted to be completely seared off.It was manually dissected and removed from the eye.Another iol was implanted without difficulty during initial procedure.Additional information has been requested and stated that, as per the surgeon opinion, the haptic seared was due to cartridge or injector.There was no patient harm reported.
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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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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation for the report of the haptic was completely seared off; 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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