The barrel of the device with the lens was returned in the opened blister tray.The plunger lock and lens stop have been removed and not returned.The plunger has been removed and not returned.The lens appears to have possibly been replaced into the loading area for return shipment.The leading position haptic is broken at the gusset areas.The broken haptic portion was not returned.The trailing haptic is bent onto the optic, adhered in dried solution.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The product investigation could not identify a root cause for the haptic damage.The observed lens damage is similar in appearance to handling related damage.The presence of the solution on the returned sample is evidence that the product was subjected to handling.The device is a preloaded device, and would not be opened for surgery prep.Viscoelastic was observed on the lens and in the device.The lens stop, plunger lock, and the plunger have all been removed from the device.The broken haptic portion was not returned.The lens appears to have possibly been replaced into the lens loading area for return shipment.Due to the presence of surgical solution, and the condition of the sample, we are unable to verify that the damage would have been present when opened.The manufacturer internal reference number is: (b)(4).
|