Catalog Number 8065751763 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Edema (1791); Burn, Thermal (2530)
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Event Date 12/23/2019 |
Event Type
Injury
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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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A surgeon reported that a patient experienced an incisional burn, in the right eye, during a cataract procedure.The patient presented with corneal edema, in the right eye, following surgery.The surgeon suspects the ultrasound was too strong.The edema persisted for 30 days.
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Manufacturer Narrative
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Correction e.1.Additional information provided in h.6.And h.10.No further information was provided.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Event Description
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A company representative offered the surgeon surgical accompaniment and support with supplies to rule out parameters, but the doctor refused, indicating he did not want to risk more patients corneas.
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Manufacturer Narrative
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Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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