This initial emdr is being submitted to fda as a reportable event that occurred in the usa.Haptic damage is indicated as a potential malfunction related to the iol, 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 a reportable event that occurred in the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: h3 - corrected to yes additional information: d9 - added date of product return g6 - type of report - noted as follow-up #1 h2 - type of follow-up - noted for corrected and additional information h6 - added codes for manufacturer's investigation: type; findings; and conclusion.Portions of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.The injector and separated haptic piece were available for investigation.The iol was not returned.No abnormalities were found in production and inspection records of the product.(serial no.: 8cv90pr1; model: prevue c).We also confirmed there were not any abnormalities on the loop pull strength test record of the material lot.(sotb-115-04) the dye test result showed the injector tip was properly coated.Proper coating allows the lens to advance.We could release a re-installed iol from the returned injector without any problems.We could not confirm the reported event of deformed haptic.Based on available information, we believe this event was not caused by our product quality.A review of the most recent complaint trending data indicates that no significant trends have been identified at this time and no capa is required as part of the product evaluation.
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