Manufacture date h4 revised to (b)(6) 2019 additional event information received that the leak was observed at the end of surgery when the surgeon removed the trocars.The incision was not self-watertight.One incision per trocar thus three sutures were needed.Surgeon sutured incisions and usual ocular pressure was acceptable.Device was not returned for evaluation, we are unable to determine a root cause.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further investigation or corrective action is necessary.
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