Catalog Number 8065751763 |
Device Problem
Unstable (1667)
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Patient Problem
Capsular Bag Tear (2639)
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Event Date 11/10/2020 |
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 customer reported that during a cataract procedure, the anterior chamber was unstable and as a result, the patient experienced a posterior capsule rupture.An anterior vitrectomy was performed and the case was completed.
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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 was received indicating the patient has fully recovered.
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Manufacturer Narrative
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The company service representative examined the system.And found it functioned as intended.The system was then tested.And met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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