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 Problems
Device Damaged by Another Device (2915); Failure to Eject (4010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/03/2024 |
Event Type
malfunction
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Event Description
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A facility representative reported during intraocular lens (iol) implant procedure, the surgeon noticed that the lens was scratched after implanting the lens.The lens was explanted and replaced with another lens during initial procedure.The surgeon tried to implant the second lens with same injector and the different cartridge and noticed that the plunger was over the lens and scratched the lens.The procedure was completed with third lens on same day without any harm to the patient.Additional information was requested, but no further information is available.
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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 a lens scratched, (in and out), plunger was over lens, no patient harm; 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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Search Alerts/Recalls
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