The device is not being sent back.Thus, a proper device analysis could not be completed nor the reported issues confirmed.It was mentioned by the customer that there was no damage noted during preparation for use indicating a product quality issue did not contribute to the reported issues.Additionally, it was stated by the customer that they are using the yamane technique to implant the lenses.This technique induces a larger amount of force while trying to position the haptics in the scleral tunnel.Our lenses are intended to be implanted in the capsular bag.Thus, the devices are being used off label.Based on the information provided, the risk assessment for the lucia product, and based on our experience and other complaints that have already been resolved, we have determined that the following factors may have caused or contributed to the damaged haptic and is not limited to: loading strategy; lens placement technique; accessory device support; poor handling during folding and inserting.The device history records were reviewed and there were no non-conformities or deviations noted during the manufacturing of the lens that would have caused or contributed to the nature of this complaint.Additionally, our lenses are 100% inspected before they leave our manufacturing site.Therefore, we are confident that the lens was processed per standard operating procedures and inspections, and met all criteria for release.
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