ALCON RESEARCH, LLC - ALCON PRECISION DEVICE INFINITI VISION SYSTEM, HANDPIECE TIP; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065750852 |
Device Problems
Complete Blockage (1094); Particulates (1451)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
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 physician reported tip of the phacoemulsification gets blocked, without aspiration and there are fragments during a cataract procedure.
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Event Description
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A physician reported tip of the phacoemulsification gets blocked, without aspiration during a cataract procedure.
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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation; 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 cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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