A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.The device reported remains implanted and therefore, not returned to lenstec.Lenstec can also confirm that there have never been any confirmed lens-related cases of postoperative pigmented membrane inflammation of our hema lenses.All endotoxin testing met specifications.There is no evidence to suggest that any aspect of this device was responsible for the reported inflammation.The assessment by the medical monitor indicated that the cause of inflammation as likely unrelated to the iol.
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