During processing of this complaint, attempts were made to obtain complete event, patient and device information.The lens was not returned; thus, a proper device analysis could not be completed.Distorted haptic are know to be caused by numerous factors including, but not limited to: loading strategy, lens placement technique, accessory device support, poor handling during folding and inserting.The reported damages were not reported during the inspection prior to use and preparation, which suggests a product deficiency did not contribute to the reported difficulties.The directions for use (dfu) provide precautions for the lens handling and injection process by stating that: "improper handling of this lens may cause damage to the haptics and the optics." a review of the device history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the lens and the reported issue appears to be related to the operational context of the procedure and not a malfunction of our device.However, the use of the additional lens to correct the patient's vision is considered medical intervention to prevent permanent impairment to the patient.Our lenses are 100% inspected before they leave our manufacturing site.Therefore, we are confident that the lens was processes per standard operation procedures and inspections, and met all of the criteria for release.
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