The product was returned for analysis and the reported complaint could not be observed.Only company handpiece device was returned.Iol was not returned.Additional observations were as follows: the device was returned in the blister tray inside the carton.The lens stop and the plunger stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted into the mid nozzle.No damage observed to the device.The correct nozzle confirmed on the device.The lens was not returned.The product investigation could not identify the root cause for the reported complaint as the lens was not returned for the evaluation.Only the company handpiece device was returned.No damage observed to the device.As the iol was not returned, we are unable to confirm lens and haptic position for advancement and 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 product contributed to the event.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
|