In regard to this complaint, an open 27-gauge eva tdc vitrectomy pack with vgpc input was received for investigation.Visual inspection confirmed the presence of a white crystalline substance on various products in the pack, especially on the vitrectome tray and between the body and the cap of the vitrectome.The substance was also detected on the cartridge and in the cutter's aspiration tube and connector.Further examination showed that the white crystalline substance is consistent with salt residue from evaporated balanced salt solution (bss).Based on the investigation results, it was concluded that one or more materials from the pack had been used or that a considerable amount of bss unintendedly ended up in the already opened blister.Hence, the reported failure could not be attributed to the product itself or its manufacture.Investigation revealed the root cause is not product or manufacturing related, but has external reasons.Therefore, risk assessments were not reviewed.
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