Model Number SA60AT |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for analysis.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.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 the lens entered the eye broken because the haptic remained trapped in the injector.The lens was removed from the patient's eye and a replacement lens was implanted with no harm to the patient.Additional information has been requested.
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Manufacturer Narrative
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The product was returned for analysis and damage was observed to the iol.No cartridge was returned.Additional observations were as follows: an empty iol case returned.Iol returned wrapped in an adhesive tape.Iol cannot be removed from the tape as it's glued from both sides.No evaluation can be performed.It is visable that iol is cut in half.One haptic is broken/torn and not returned.No cartridge/injector was returned.The product investigation could not identify the root cause for the reported complaint as only the iol was returned for evaluation.No cartridge/injector was returned.Due to this, we are unable to complete a thorough investigation to determine a root cause.The reported complaint is lacking in relevant information such as viscoelastic used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the iol contributed to the event.The dimensions of the lens could not be tested due to the condition of the returned sample.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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