MAUDE Adverse Event Report: AMO(HANGZHOU) CO., LTD. CONSEPT 1 STEP; DISINFECTING SOLUTION

Model Number 07167X

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Red Eye(s) (2038); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Additional information: age or date of birth, weight, and ethnicity: unknown/no information.Date of event: unknown/no information.Manufacturer telephone number: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Consumer reported that she usually uses complete double moist multipurpose solution but mistakenly purchased the concept 1-step peroxide solution.She used concept 1-step peroxide solution in the same way she normally uses complete double moist multipurpose solution and consequently experienced severe irritation in her eyes.She visited the eye clinic which prescribed eye-drops and oral medication.Prescription: hyaluronate na ophthalmic solution, cravit ophthalmic solution 1.5%, rinderon 0.001%, oral medicine (drug name was unknown).She felt better after using the prescribed medicine and was told that her eyes had recovered.After her eyes recovered, she soaked her contact lenses in the disinfectant concept 1-step peroxide solution.Her eyes got irritated again.No further information was provided.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: july 19, 2021.Section h3: evaluated by manufacturer: yes.Additional information: device evaluation: chemical test was conducted to the returned sample, all the tested items met the product specification, no product deficiency was confirmed.Manufacturing record review: reported lot number ze06099 was a packaging lot-kit.Lot# of the solution was ze06097.The manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that one additional complaint was received for this production order.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.

Manufacturer Narrative

This follow-up report is to correct the initial submission.In the initial report the following fields were not addressed and are now updated accordingly: section d4, catalog number: 94019ja.Section d6a, if implanted, give date: not applicable as this is not an implantable device.Section d6b, if explanted, give date: not applicable as this is not an explantable device.Section h6, component codes: 4755 - part/component/sub-assembly term not applicable section h6, health effect-clinical code: omit 2038 - red eye(s) s there was no report of red eyes.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: CONSEPT 1 STEP
• Type of Device: DISINFECTING SOLUTION
• 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: 12163560
• MDR Text Key: 266027406
• Report Number: 3004178847-2021-07009
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 24987617003450
• UDI-Public: (01)24987617003450(17)210131(10)ZE06099
• 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,Followup
• Report Date: 09/12/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: 07167X
• Device Catalogue Number: 94019JA
• Device Lot Number: ZE06099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 10/26/2021; 08/29/2022
• Supplement Dates FDA Received: 11/24/2021; 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female