MAUDE Adverse Event Report: AMO(HANGZHOU) CO., LTD. CONSEPT 1-STEP; ACCESSORIES, SOFT LENS PRODUCTS

Model Number 7167X

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

Patient Problems Purulent Discharge (1812); Inflammation (1932); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Additional information: age or date of birth, weight, and ethnicity: unknown/no information.Date of event: exact date unknown, not provided, best estimate is during 2021.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Received report from a consumer who experienced severe irritation in both her eyes.The severe irritation occurred four out of nine times when wearing her contact lenses.She cared for her contact lenses with concept 1-step solution.Consumer reassured us that she added the neutralizing tablet and the solution had turned pink.She shook the lens case many times, nevertheless she still experienced irritation four times.On one occasion she re-did the care of her contact lenses, but she still experienced irritation.Patient visited an eye clinic and steroids were prescribed; the name was not provided.After using the medication the irritation subsided.At the time of this report, she was experiencing mucus discharge.She refused to be contacted regarding the course of her symptoms.No further information was provided.This report is for the solution.A separate report is being submitted for the neutralizing tablets.

Manufacturer Narrative

Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that 10 complaints were reported in the previous 12 months with the duration from 11/16/2020 to 11/16/2021.No product deficiency was confirmed for the similar issue.Conclusion: based on the investigation, no product deficiency was identified.

• Brand Name: CONSEPT 1-STEP
• 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12595595
• MDR Text Key: 275472760
• Report Number: 2020664-2021-07374
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(17)240327(10)ZJ05112
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P850088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2024
• Device Model Number: 7167X
• Device Catalogue Number: 90252-3RKB
• Device Lot Number: ZJ05112
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2021
• 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: NEUTRALIZING TABLET LOT UNKNOWN; NEUTRALIZING TABLET LOT UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Sex: Female