If explanted, give date: not applicable, as lens remains implanted.Device evaluation: product evaluation cannot be performed as per the initial report, the lens remains implanted.The complaint issue reported could not be verified, and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated, and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.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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Additional information: the complaint was based upon a subjective estimate made by the investigator from a slit-lamp measurement.For this study, we have also been doing independent analysis of the intraocular lens (iol) photos taken at each visit.These are objective measurements of the actual iol axis.Based on this objective measurement, the actual amount of iol rotation for the subject below is less than 01 degrees.There is still no surgical intervention planned, and the subject has exited the study.Subject visit schedule page study eye delta angle from base (b)(4) po 1 day - second eye analyst 1 review os 0.987; (b)(4) po 1 day - second eye analyst 2 review os 0.374.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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