The cartridge was returned inside the opened pouch, that had been taped closed.Viscoelastic was observed dried in the cartridge.The cartridge nozzle was stressed.An aneurysm formed, after the parting line and extended into torn tip damage along the right side of the tip.The tip has stress.The cartridge has evidence of being placed into a handpiece.An iol product identification label had been affixed to the clear side of the pouch.This product was identified as the associated lens.Event date, patient initials, birthdate, doctor initial, and cartridge info was also handwritten on the pouch.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation, indicates the product met release criteria.The customer indicated, the use of a qualified diopter lens, handpiece and viscoelastic.The product investigation could not identify a root cause for the reported complaint.Qualified associated products were used.The extreme damage to the tip was observed.This type of damage typically occurs, if the lens is not positioned correctly for advancement.If there is a lack of viscoelastic between the lens and the cartridge lumen.If the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge.If the handpiece plunger is not positioned at the trailing optic edge, it can allow the lens to fold around the plunger tip, making it too large to correctly advance through the narrow tip of the cartridge.Which could cause damage to the tip or the lens.The manufacturer internal reference number is: (b)(4).
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