Udi #: (b)(4).Age/date of birth: unknown/not provided.(b)(4).Device evaluation: complaint device was not returned for analysis.The complaint cannot be confirmed.The manufacturing production order (po) was evaluated and the devices were manufactured within specifications.The unit`s were released according to specification.There is no associated deviation or non-conformity report related to this complaint.The complaint related test is the optical measurement performed at final inspection.The in-line optical inspection data was reviewed and results showed that the lens was manufactured within power specification.A review of the complaints related to the production order was performed and the results revealed that no other complaints for this order number.A historical complaint data review was performed and results did not identify any product deficiency.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the manufacturing record review, complaint data review and labeling review, no product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.
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