Additional information provided.There have been no additional complaints reported against the finished goods lot and the device history records shows the product was released per specifications.The customer reported that they had a fiber stuck on an intraocular lens (iol) that they believe came from the custom pak.The scrubs found fibers stuck to their gloves after rubbing their hands across the back table cover.The customer did not retain a sample for this complaint report; visual inspection or particulate testing could not be conducted.Without a sample or photo, the root cause cannot be determined.Possible root cause include an error in the warehouse, an error made during the custom pak internal manufacturing process and an error made during the supplier¿s manufacturing process.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.Warehouse operations states that product shall be stored in containers that are closed to the warehouse environment in order to prevent mix-ups and to prevent product from being coated with dust or otherwise soiled.Action will not be taken for this occurrence.The account manager is already working with the sales admin to change the mayo cover in the customer¿s pak.The manufacturer internal reference number is: (b)(4).
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