This initial emdr is being submitted to fda as a reportable event that occurred in the usa.Posterior capsule rupture is indicated as a potential adverse event related to iol implantation, as covered under the warnings section of the product's instructions for use (ifu).Regarding section h6 - manufacturer's codes for: type of investigation, findings, and conclusion are pending device return and completion of product investigation.Once the product investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for type of investigation, findings, and conclusion.
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This follow-up #1 emdr is being submitted to fda for an event that occurred inside of the usa.The report includes additional information not available/included in the initial report.Additional information: g6 - type of report - noted as follow-up #1 h2 - type of follow-up - noted for additional information h6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product was not returned to the manufacturer.Injector, iol and product information were not available for investigation.The product was not returned and appearance check was not performed.Serial number and model information were not available, so risk assessment and trendingcannot be performed.Will be re-assessed if additional information is received.
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