This initial emdr is being submitted to fda for an event that occurred inside of the usa.Capsular rupture is indicated as a potential adverse event related to the iol, as covered under the adverse events section of the product's instructions for use (ifu).B1pc: pkg-19-388 00 i51-09-153.01_b1py, b1pc 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 report # 1 emdr is being submitted to fda for a reportable event that occurred inside 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.The investigation was conducted, with the methods and results as noted below.The serial number was not provided so the production and inspection records of the product could not be reviewed.(serial no.: unknown; model: b1pc).The exact root cause was not determined.However, based on the available information and our investigation, we believe this event was not caused by our product quality.No capa is required as part of the product evaluation.
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