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

Model Number	9424X
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Corneal Ulcer (1796); Eye Infections (4466)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complete multipurpose solution was not returned for evaluation; therefore, a failure analysis of the complaint product 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.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
While conducting a search of the maude adverse events database, this report was identified.The report is a corneal ulcer by pseudomonas in patient's right eye, followed three weeks later by pseudomonas oleaginous and corneal ulcer left eye.Complete multipurpose solution was sent for cultures, grew pseudomonas.No additional information provided.

• Brand Name: COMPLETE
• Common Device Name: 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
• MDR Report Key: 12344777
• Report Number: 3004178847-2021-07016
• Device Sequence Number: 3938185
• Product Code: LPN
• UDI-Device Identifier: 30827444000639
• UDI-Public: (01)30827444000639(17)211223(10)ZE08084
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K014202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/23/2021
• Device Model Number: 9424X
• Device Catalogue Number: 93506LCAHZ
• Device Lot Number: ZE08084
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CONTACT LENS
• Outcome Attributed to Adverse Event: Other; Required Intervention