(b)(4).Device evaluation: the product was discarded.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product 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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The customer account reported that after implantation of a tecnis one-piece monofocal intraocular lens (iol) in the patient's right (od) eye, it had to be removed and replaced with another lens due to a capsule tear.The replacement lens is an alcon (ma60ac) lens.A vitrectomy along with sutures were required, and the lens was cut and discarded.Patient was reported to be doing fine post-operatively.No further information provided.
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