Model Number AU00T0 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
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Event Description
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A nurse reported that, during intraocular lens (iol) implant procedure, the injector tip was found to be defective on the injectable lens.The implant was still usable and implanted in the patient.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 from nurse that, the issue was noticed during the deployment of the lens.It did not cause any harm but it had the potential.
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Manufacturer Narrative
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Only the device was returned loose inside the opened carton.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was fully deployed.The plunger extended beyond the nozzle tip due to being fully deployed.The anterior soft flange of the plunger tip was slightly bent backward.The flange is flexible by design to help facilitate a successful lens delivery through the device.There was no damage observed to the plunger.There was no damage observed to the device body or nozzle.A photo was provided that matched the returned product.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic information was not provided.The used device was evaluated.There was no problem found with the device or the plunger.The anterior soft flange of the plunger tip was slightly bent backward.The flange is flexible by design to help facilitate a successful lens delivery through the device.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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