The side effects described by the patient is documented as a potential risk of the smile procedure in the visumax instruction for use.The voluntary report received by czmi does not contain any product information such as serial number or contact information of the patient, physician or user facility.Therefore, the manufacturer is unable to perform a detailed investigation or confirm the alleged injury.
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Carl zeiss meditec, inc.Received from the fda a voluntary event report mw5086435, which was submitted by a patient.In the voluntary report, the patient reported experiencing various side effects post refractive correction surgery using the visumax laser system.The patient did not allege a device malfunction.
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