Catalog Number 8065977758 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.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 health care professional reported that during an intraocular lens (iol) implant procedure, cartridge diameter was larger, making it difficult to incise scalpel.Additional information was received stating there was no patient harm.
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Manufacturer Narrative
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The used cartridge was not returned.Two photos were provided of a cartridge being held by an ungloved hand.The view was from the bottom mid-body through the tip.Unable to determine usage.No damage or abnormalities observed.Company cartridges have a larger diameter tip than the other cartridges.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Two photos were provided.No damage or abnormalities observed.Cartridge manufacturing is a validated operation, with specifications that are maintained and documented.No changes have been made for the manufacturing of cartridges.Supplier manufacturing records as well as their certificate of compliance verify the dimensional measurements are within specifications.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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