The product was returned for analysis and the reported complaint could not be confirmed.The device was returned in a clear plastic bag.The lock-out assembly has been removed.The plunger is oriented correctly.The plunger has been fully advanced outside the tip of the device.Viscoelastic is dried in the device.No damage or abnormalities observed.No lens returned.Haptic position for the advancement cannot be confirm.Only the device is available for evaluation.No damage was observed to the device.The presentation of straight leading haptics is addressed in the product instructions for use (ifu) where it is provided that delivery may proceed with caution and should be managed based on the outlined instructions.Straight leading haptics may occasionally occur, close adherence to the ifu provides the best opportunity for optimal delivery.Possible associated root cause factors may also include: *use of a non-qualified viscoelastic or bss in the delivery system.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.*excessive delay between device preparation and subsequent delivery resulting in the potential for haptic unfolding.*use of the delivery system at operating room temperatures outside of the recommended range of 18 °c (64 °f) to 23 °c (73 °f).Ovd should be allowed to come to operating room temperature over a 30 minute timeframe prior to use.Any of the above listed causes alone, or in combination, may create the reported event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
|