A johnson and johnson vision care (jjvc) sales representative received a report from a product dealer/distributor.Reporter indicated that a junior high student suffered several corneal infections in a short time frame.Reporter asked if there are any problems with the combination use of contact lenses air optix (alcon, 2 weeks soft contact lenses) and the complete multipurpose solution double moist.The exact model of the contact lenses is unknown.However, according to the reported per the directions for use of certain air optix contact lenses, these lenses are not to be used with multipurpose solutions that contain the disinfectant agent polyhexanide hydrochloride as an active ingredient.The incident date for the right eye is (b)(6) 2022 and for the left eye is (b)(6) 2022.The patient sought medical attention and was diagnosed with bacterial keratitis.An eye ointment was prescribed; however, the name was not provided.At the time the event was reported to johnson and johnson the patient had not recovered.No further information is available.This report is for the right eye.The event for the left eye is reported in medwatch 3012236936-2022-02474.
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Age/date of birth: unknown/no information.Patient weight: unknown/no information.Ethnicity: unknown/no information.Race: unknown/no information.Expiration date: unknown as the lot number was not provided.If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.Establishment name and address: unknown/not provided.Initial reporter telephone number: (b)(6).Device manufacture date: unknown, as it has not been provided by the external manufacturer.The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
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Additional information: johnson and johnson (jnj) has reviewed the instructions for use (ifu) for the alcon airoptix contact lenses.It was confirmed that the ifu does not contain any contraindication, warning or precautions with the use of polyhexidine hydrochloride.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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