(b)(4).Device evaluation: field service engineer (fse) visited site and confirmed error in log however, was unable to observe the issue during testing.Verified phaco mode function and calibration.Performed annual preventative maintenance (pm) while onsite.System meets jnj vision specs.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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