Additional information provided in d.9, h.3, h.6 and h.10.The lens was returned for evaluation.Solution is dried on the lens.One haptic is broken in the distal area (not returned).Associated products were not provided.It is unknown if qualified products were used.The lens model is only qualified for use in the company a and b cartridges.Broken haptic damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company's release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.The manufacturer internal reference number is: (b)(4).
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