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

Model Number 9424X

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Corneal Ulcer (1796); Eye Infections (4466)

Event Date 05/21/2021

Event Type  Injury  

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 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
• 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 ; 200, 4th ave. hz e&t dvlp. zone; hangzhou, zhejiang 31001-8 ; CH 310018
• MDR Report Key: 12344777
• MDR Text Key: 267344682
• Report Number: 3004178847-2021-07016
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 30827444000639
• UDI-Public: (01)30827444000639(17)211223(10)ZE08084
• Combination Product (y/n): N
• PMA/PMN Number: K014202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2019
• 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
• Treatment: UNKNOWN CONTACT LENS
• Patient Outcome(s): Other; Required Intervention