The device with the lens was returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger is at the trailing optic edge.The lens is advanced to mid-nozzle.The trailing haptic is folded in on the optic.The leading haptic is extended.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The returned device does not match the reported events.The lens has not been delivered and no lens damage was observed.No problems are observed with the returned device.The plunger, lens and haptic positions are acceptable.A straight leading haptic is observed.Straight leading haptics are not a product malfunction.This is an acceptable position per the diagrams provided in the directions for use (dfu).A straight leading haptic may occur: due to the normal folding variations as indicated in the dfu diagrams.If the initial plunger advancement is faster than the recommended target, the leading haptic may be forced past the internal folding feature.If the viscoelastic fill rate is too fast the folding effect on the leading haptic is minimized.If there is excessive delay between the device preparation and subsequent delivery the leading haptic may start to unfold.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 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 or contribute to incorrect haptic folding.Any of the above listed causes alone, or in combination, may create the reported event.The customer indicated a non-qualified viscoelastic was used.Material properties of non-qualified viscoelastics may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the dfu, only qualified viscoelastics must be used in conjunction with the device.All other viscoelastics are not qualified for use.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to lens delivery issues and /or damage.The use of non-qualified viscoelastics is considered a failure to follow the dfu and is not recommended under any circumstance.The manufacturer internal reference number is: (b)(4).
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