ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR
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Model Number III |
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 04/26/2022 |
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 nurse reported that during a cataract extraction with intraocular lens (iol) implant procedure, a very clear mark or scratch was observed in the middle of the lens after the iol was delivered in the bag.The lens has been cut for removal from the patient¿s eye.The replacement lens was used and the surgery was completed.There was patient contact with the product but no patient harm was reported.The patient's symptoms were resolved.Additional information was received stating customer don¿t know why or were the mark/ scratch came from.They more likely think that it was from the forceps, or the handpiece plunger.
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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 scratch in middle of lens; 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 is available, therefore, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).
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