Model Number SA60AT |
Device Problems
Failure to Deliver (2338); Failure to Eject (4010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge.The file does not indicate what handpiece was used.Two viscoelastics were indicated, only one is qualified for this lens with the qualified cartridge and handpiece combinations.The product investigation could not identify a root cause for the reported.Information was provided that the reason for the iol being stuck in the cartridge was likely due to user error.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) implantation, the iol got stuck in the cartridge.Doctor was unable to successfully deploy the iol, part of the iol was stuck in the cartridge, which was unable to release.Doctor then remove the lens and implanted another lens.Patient treated as intended.
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Manufacturer Narrative
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(b)(4).The lens was returned loose in a bag inside the carton.The lens case was also returned.A small amount of viscoelastic is observed on the lens.A small scratch is observed on the anterior optic surface near the edge.This damage is similar to damage caused by an instrument used to grasp the lens.It is unknown of a qualified product was used.The root cause for the reported complaint of iol stuck in the cartridge could not be determined.The lens was not returned in the reported condition.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The ifu also instructs to completely fill the cartridge with ovd (diagram provided) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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