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 Corneal Abrasion (1789); Discomfort (2330)

Event Date 01/02/2022

Event Type  Injury  

Event Description

Consumer reported that she experienced irritation in her right eye when wearing her contact lenses after taking care of them with consept 1-step solution.Reportedly, the product was used properly.The contacts lenses used were acuvue oasys (bi-weekly).The bottle was newly opened and so were the contacts, opened (b)(6) 2022, and used.The next morning (b)(6), the consumer again experienced irritation when wearing the contact lens.Consumer sought medical attention at an eye clinic.The doctor said her cornea had small scratches, but the cause was unknown.She was prescribed tearbalance ophthalmic solution 0.1%, and gatiflo ophthalmic solution 0.3%, and wore eyeglasses.The symptoms subsided.No further information was provided.This report is for the disinfecting solution.A separate report is being submitted for the neutralizing tablets.

Manufacturer Narrative

The device has not returned for evaluation.Therefore, a visual 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.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Manufacturer Narrative

The device has not returned for evaluation.Therefore, a visual 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.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Event Description

Consumer reported that she experienced irritation in her right eye when wearing her contact lenses after taking care of them with consept 1-step solution.Reportedly, the product was used properly.The contacts lenses used were acuvue oasys (bi-weekly).The bottle was newly opened and so were the contacts, opened (b)(6) 2022, and used.The next morning (b)(6), the consumer again experienced irritation when wearing the contact lens.Consumer sought medical attention at an eye clinic.The doctor said her cornea had small scratches, but the cause was unknown.She was prescribed tearbalance ophthalmic solution 0.1%, and gatiflo ophthalmic solution 0.3%, and wore eyeglasses.The symptoms subsided.No further information was provided.This report is for the disinfecting solution.A separate report is being submitted for the neutralizing tablets.

Manufacturer Narrative

Additional information section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: feb 22, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: product chemical test was conducted to the returned sample, all the tested items met the product specification, no product deficiency was confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Complaint data was trended by the reported lot number: zj05556.One complaint was reported in previous 12 months.No product deficiency was confirmed for the similar issue conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13463734
• MDR Text Key: 285155587
• Report Number: 3012236936-2022-00205
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(17)240413(10)ZJ05556
• 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: 04/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/13/2024
• Device Model Number: 7167X
• Device Catalogue Number: 90252-3RKB
• Device Lot Number: ZJ05556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TABLET LOT# 90996, ACUVUE OASYS CONTACT LENS
• Patient Outcome(s): Required Intervention
• Patient Sex: Female