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

Model Number 9081X

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

Patient Problems Hyperemia (1904); Keratitis (1944); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Additional information: age, weight and ethnicity: unknown/no information.Date of event: the exact date is unknown, the best estimate is in the beginning of (b)(6) of 2021.Device expiration date: batch details as provided by the manufacturer indicate the product expiration date is september 2022, therefore september 30, 2022 is provided as the best estimate date.Device manufacture date: batch details as provided by the manufacturer indicate the product was manufactured october 2020, therefore october 01, 2020 is provided as the best estimate date.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Event Description

Consumer reported that she experienced irritation and red eyes when wearing her contact lenses after taking care of them with consept 1-step solution.This happened after using the second bottle which was around the beginning of (b)(6) 2021.She was concerned about having any further problems with her eyes and visited an eye clinic.She was diagnosed with keratitis and was prescribed the following eye drops: fluorometholone ophthalmic solution, levofloxacin ophthalmic solution and hyalein ophthalmic solution.She was informed that her symptoms would subside in about two weeks.She used 1-day contact lenses for a week to be safe.It was noted the usage of the product was proper.At the time of this report, she had recovered.However, towards the end of (b)(6) 2021 the consumer re-started the use consept 1-step solution to take care of her 2-week contact lenses.Again, she experienced irritation and red eyes, but she recovered with no medical intervention.No further information was provided.

Manufacturer Narrative

Corrected data: method codes 3331 and 4109, results code 213, and conclusion code 67 were provided in the initial report, however, the manufacturer narrative was not included, therefore, it is being provided in this follow-up report.Additional information section d9: device available for evaluation? yes section d9: date returned to manufacturer: oct 28, 2021 section h3: evaluated by manufacturer: yes device evaluation: the retain and return sample were analyzed.The samples comply to specifications.Results of retain sample and return sample found comparable, no abnormality observed.A product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.The complaint log for the past two years from the date of receipt of the complaints has been reviewed and no justified complaint of similar nature was found.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: OXYSEPT 1
• 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: 12524387
• MDR Text Key: 273085540
• Report Number: 2020664-2021-07288
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• 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: 12/07/2021

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: 09/30/2022
• Device Model Number: 9081X
• Device Catalogue Number: 40505JA
• Device Lot Number: 89326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSEPT 1-STEP SOLUTION LOT ZH07081; CONSEPT 1-STEP SOLUTION LOT ZH07081
• Patient Outcome(s): Required Intervention
• Patient Sex: Female