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 08/02/2023 |
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 physician reported that, during intraocular lens implantation surgery, during loading, the plunger went over the lens.The technician tried the reload the lens but the same thing happened.Hence the physician decided to change the plunger and the 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 inserter went over lens and lens was likely scratched from being loaded/reloaded; 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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Event Description
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Additional information received stating that, the lens was likely scratched from being loaded/reloaded.
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Search Alerts/Recalls
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