The returned samples were inspected per facility procedure (b)(4) and were determined to be visually conforming.The final customer lot was identified as sterile lot 112062m, manufactured in jun-2015.A device history record review for the lot was conducted.No anomaly was found during the device history record review.The product was released based on the product¿s acceptance criteria.No additional investigation is required based on device history review.A complaint history review indicates this is the third complaint received against the reported lot.The three complaints were received concurrently from the same account.The reason for the posterior capsule tear cannot be confirmed from the evaluation of the returned sample.Possible contributing factors are using the tip more than 10 times and the improper placement of the tip into the holder stand.Correspondence included with the complaint stated the facility practice includes usage in excess of the 10 times described in the directions for use.During cleaning, the direction for use instructions must be adhered to or the tip may become damaged.Silicone i/a tips must also be inspected for any damage present prior to each use.This investigation was opened for new tips, however, the returned samples were conforming to visual inspections and did not point to a cause for the rupture of the posterior capsule.(b)(4).
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