Model Number CNA0T0 |
Device Problems
Failure to Eject (4010); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A pharmacist reported that during intraocular lens (iol) implantation, the lens becomes trapped in the lens cartridge and resisted the force that the doctor applied to the injector.For this reason, the specialist decided not to perform this maneuver anymore and completed procedure by another lens with no patient harm.Additional information has been requested.
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Manufacturer Narrative
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Additional information was provided in h.3., h.6.And h.10.The product was not returned for analysis.Received photos shows a company device beside an unknown peel pouch.An intraocular lens (iol) is on top of or inside the peel pouch.Iol condition cannot be verified on the returned photo.Based on our observation of the attached photo, the reported complaint cannot be confirmed.A definitive determination of iol condition cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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