Product evaluation: the lens was returned positioned incorrectly in the lens case.Solution is dried on the lens.Both haptics are bent in the gusset and distal area.The optic is torn/split/cracked in multiple places.We are unable to conduct a fold inspection due to the extensive optic damage.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause cannot be determined for the complaint.Further clarification was not provided for the complaint of "product failed the testing - iol was folded".It is unknown what steps/process was used for the reported ¿testing¿ of the lens prior to customer use.Each individual lens is subjected to multiple 100% inspections and tests during the manufacturing process prior to final quality release from the manufacturing facility in order to determine if the lens meets acceptability by set quality standards.The directions for use does not condone nor recommend additional testing activities prior to the use of the lens, as lens damage may occur due to mishandling.A fold test could not be conducted due to the damage of the returned lens.There have been no other complaints reported in the lot number.This product malfunction was originally reported under an alternative summary report.The sample has been returned and investigation was updated, which prompts evaluation and conclusion coding to be updated.As the alternative summary report has been revoked, the updated information (product investigation and coding) is being sent via this 3500a report.The manufacturer internal reference number is: (b)(4).
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