Catalog Number 8065977763 |
Device Problem
Sticking (1597)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).
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Event Description
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An ophthalmic surgeon reported that during a cataract with intraocular lens (iol) implant procedure, the case proceeded normally until the lens insertion, utilizing a cartridge and handpiece.The surgeon felt the iol was "stuck", then scraped the endothelium and descemet's membrane when it was released from the cartridge.Additional information has been requested.There are two medical device reports associated with this event.The first report is for the iol and the second report is for the cartridge.
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Manufacturer Narrative
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Evaluation summary: additional information indicated the type handpiece that was used with the lens.The lens diopter was not provided.It is unknown if this combination was qualified.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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