Model Number AU00T0 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 12/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported during the implant of an intraocular lens (iol) using a preloaded delivery system, the lens 'rocketed through the posterior capsule'.The surgeon reports there was no difference in resistance during injection and everything seemed completely normal until suddenly the lens shot in.Additional information was requested.
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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 reports the lens was rotated with the haptics 90 degrees away from the hole.The viscoelastic was removed and there was no vitreous encountered.The lens centration is excellent and stable.
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Search Alerts/Recalls
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