MAUDE Adverse Event Report: AMO(HANGZHOU) CO., LTD. COMPLETE; ACCESSORIES, SOFT LENS PRODUCTS

Model Number 8941X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Eye Infections (4466)

Event Date 09/12/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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 left eye.The event for the right eye is reported in medwatch 3012236936-2022-02473.

• Brand Name: COMPLETE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): AMO(HANGZHOU) CO., LTD.; 200, 4th ave. hz e&t dvlp. zone; hangzhou, zhejiang 31001 8; CH 310018
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15629454
• MDR Text Key: 301978668
• Report Number: 3012236936-2022-02474
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K014202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 8941X
• Device Catalogue Number: 93926JA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention