Additional information provided in h.3., h.6., and h.10.The product was not returned.All product and batch history records are quality reviewed prior to product release.The provided photos were reviewed.Two photos were provided.The photos show the lens in the eye.Two marks are observed.The marks are not in the fold path.The marks are oriented to the right of the center of the optic.The marks are not straight and are slightly curved in opposite directions.The indicated marks are not similar to any type of marks previously observed on delivered lenses.These marks may be related to a handling technique at the site.A qualified cartridge was indicated.The handpiece information was not provided.It is unknown if a qualified handpiece was used.A non-qualified viscoelastic was indicated.The product investigation could not identify a root cause for the reported marks.Based on review of provided photos, the indicated marks are not similar to typical loading or delivery damage.Two photos were provided for this file.Two marks are observed.The marks are not in the fold path.The marks are oriented to the right of the center of the optic.The marks are not straight and slightly curve in opposite directions.These marks may have been cause by an instrument or technique at the facility.The manufacturer internal reference number is: (b)(4).
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