The device with the lens was returned.The plunger is oriented correctly.Inadequate viscoelastic is observed in the device.The plunger has been advanced under the lens.The lens is advanced to the fill line.The trailing haptic is misfolded under the optic.The optic is misfold.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.A plunger underride was observed.The root cause may be related to a failure to follow the directions for use (dfu).Inadequate viscoelastic was observed in the device.The dfu instructs: fill the device until viscoelastic can be observed flowing to the line on the nozzle tip.This will require approximately 0.2 ml of viscoelastic.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to underride the lens.Plunger underride may occur: ¿ due to rapid advancement faster than the dfu recommended rate.¿ due to the use of a non-qualified viscoelastic.Material properties of non-qualified viscoelastics may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If inadequate viscoelastic is placed in the device, this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to underride the lens.If the device is overfilled with viscoelastic, this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.Top coat dye stain testing was conducted with acceptable results.The manufacturer internal reference number is: (b)(4).
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