(b)(6).(b)(4).Device evaluation: the actual complaint product was not returned for investigation.A photograph of the reported complaint product was received and identifies lot reported by the customer.Retain product testing was performed.A visual inspection of the lot was performed.The retained product met specifications for appearance, component integrity, and product leakage.Manufacturing record review: a review of the manufacturing records were performed.The production process records were found to be acceptable.There were no same/similar non-conforming materials found during packaging, in-process inspection and quality assurance release inspection.There were no non-conformances related to the reported complaint.In conclusion, reported lot was deemed acceptable for release.Based on the results of the investigation, it was identified that the reported product was likely over labeled by the amo distributor.No product deficiency was identified in the investigation.All pertinent information available to abbott medical optics has been submitted.
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It was reported that complete easy rub (cer) supplied to the (b)(6) market had incorrect manufacturing and expiration dating on the product.Complaint product displayed a manufacturing date of 11/2015 and expiry of 11/2018 while per product manufacturing records, the last batch supplied to (b)(6) was in 2014, with an expiry date in 2017.Pictures of complaint product were provided.The complaint reporter (wholesale customer) returned product, but returned product lot# (zp02988), which was not the lot that was initially reported (zp02410).As two (2) product lots have been identified, an mdr for each lot will be provided.This report represents lot zp02410.
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