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Model Number CC065S |
Device Problem
Product Quality Problem (1506)
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Patient Problem
Capsular Bag Tear (2639)
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Event Date 08/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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The product was discarded, therefore an evaluation cannot be performed.Review of the video provided by the surgeon shows the posterior capsule tear open at or near the same time that a cluster of bubbles were released from the tip of the cannula, during the viscoelastic injection.Overinflating the bag with viscoelastic or some preexisting microscopic defect in the posterior capsule can blow out the bag.The cause of the tear cannot be determined due to unknown variables that could contribute to a posterior capsule tear, such as surgical conditions, patient related factors like disease, or other conditions of the eye that can increase the probability of a capsule rupture.The investigation is ongoing and a follow-up report will be submitted upon completion.
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Event Description
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Reportedly, there was posterior capsule rupture after a viscoelastic injection into the eye.Allegedly, there were more bubbles than usual.Reverse optic capture of intraocular lens (iol) and power adjustment of iol were performed.Patient outcome was normal and the eye looked good.
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Manufacturer Narrative
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Updated d4, g3, h2, h4, h6, h10./11.A review of the device history record (dhr) found no nonconformities or anomalies related to this complaint.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, the root cause could not be determined.
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Search Alerts/Recalls
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