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 10/03/2021

Event Type  Injury  

Manufacturer Narrative

Age or dob, weight, ethnicity: unknown/no information.Additional concomitant product contact lens, unknown model, and type.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Event Description

Consumer reported that he experienced severe irritation in his eyes when wearing his contact lenses which he maintained with consept 1-step.After an hour he visited an eye clinic.He was informed that his eye was scratched and was prescribed hyaluronic acid eye drops of and levofloxacin ophthalmic solution.It was reported the product was properly used.At the time of this call his eyes had recovered.No further information was provided.

Manufacturer Narrative

Additional information section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: nov 15, 2021.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 zj04286.One complaint was reported in the 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12756528
• MDR Text Key: 280752671
• Report Number: 2020664-2021-07671
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(17)231218(10)ZJ04286
• 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: 01/18/2022

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: 12/18/2023
• Device Model Number: 7167X
• Device Catalogue Number: 90252-3RKB
• Device Lot Number: ZJ04286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2020
• 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 TABLETS LOT 89979
• Patient Outcome(s): Required Intervention
• Patient Sex: Male