Model Number AU00T0 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 12/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: 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) in a preloaded delivery system, there was a break/tear in the patient's capsule.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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Manufacturer Narrative
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The device with the lens was returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger is at the trailing optic edge.The lens is advanced to mid-nozzle.The trailing haptic is folded in on the optic.The leading haptic is folded back toward the optic.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.A root cause for the reported issue could not be determined.A malfunction has not been indicated against the device.No problems are observed with the returned device.The plunger, lens and haptic positions are acceptable.The lens has not been delivered and is still intact in the nozzle of the device.Information was provided that there was a tear in the capsule and the surgeon changed to a different lens.The cause of the "tear" was not provided.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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