Catalog Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Edema (1791); Clouding, Central Corneal (2228)
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Event Date 07/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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No sample has been received by manufacturing for evaluation.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.(b)(4).
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Event Description
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A surgeon reported that a viscoelastic product was used during a cataract surgery and within seconds the cornea became edematous and cloudy, followed by lenticular clouding and edema in less than 60 seconds.Additional information has been requested.Additional information received clarified that the scheduled procedure was aborted.The physician stated that they made a single incision and then used the phaco to remove some of the white material that had formed.Afterwards, the patient was taken to the pacu for discharge.The physician indicated that follow up will be performed through the physician's office.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information received confirmed that the patient was doing well.
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Manufacturer Narrative
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Complaint trending reviewed for the lot code provided.No similar complaint found.One assembled syringe including product was received as complaint sample.No component deviations were reported related to the complaint.The chemical lab tested the clarity of the sample and the results are within specifications.The ph and osmolality could not be tested as not enough product was available in the syringe.Batch records were reviewed and all testing results met specifications for this lot code at the time of release.Additionally, there were no deviations noted during batch record review.All initial test results are confirm, no production deviations that could cause the reported defect were reported and the returned sample is conform for the clarity.As not enough product was available in the syringe for further testing (ph and osmolality), no conclusive root cause can be determined.This is an isolated incident for this lot.Based on the investigation results (not enough product) we are unable to verify the complaint and therefore no capa is initiated.However further trending is performed.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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