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

Model Number 7167X

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

Patient Problem Eye Infections (4466)

Event Date 09/07/2023

Event Type  Injury  

Manufacturer Narrative

Section a2, a4 and a5: unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Section d4: lot number: unknown, information not provided.Section d4: expiration date: unknown, as the lot number was not provided.Section d4: udi number: unknown, as the lot number was not provided.Section e1: initial reporter last name: information unknown/not provided.Section e1: initial reporter telephone number: (b)(6).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed because the lot number of the complaint product is unknown.Since the lot number is unknown, the complaint history review could not be performed.However, it was noted that there were no other complaints reported against this type of lens solution in the previous twelve (12) months.Conclusion: since the sample of the complaint product was not returned, and lot number is unknown, it is not possible to determine a malfunction and/or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a patient experienced eyes infection when using the oxysept eye solution.Patient stated that she wore ortho-k hard lens overnight (while sleeping).Patient indicated that she could not open her eyes in the morning and when she is able to open her eyes they were red, tearing, and light sensitive.The symptoms last for about 40 minutes and her eyes feel better afterwards.Patient did not apply any eye drops.Event occurred in (b)(6) 2023.Patient experienced the same issues again on (b)(6) 2023 for the second time but patient stated that this time the symptoms lasted the whole day.Hence, patient consulted a doctor and was diagnosed with eye infection and toxic reaction.Patient stated that she has been using oxysept solution and ortho-k hard lens together for 5-6 years, and has not had these issues before.Patient provided that due to this reason, the doctor diagnosed her with toxic reaction.Doctor advised the eye infection could be due to oxysept solution ingredients.Culture test performed by the doctor confirmed the diagnosis.Patient was prescribed ciloxan eye drops 5ml.Patient current eye condition is unknown.The patient has not fully recovered; however, the symptoms are improving.Patient discarded the bottles.The product lot number is unknown.No further information was provided.

• Brand Name: OXYSEPT
• 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: 17891604
• MDR Text Key: 325228145
• Report Number: 3012236936-2023-02429
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7167X
• Device Catalogue Number: 90273AS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEUTRALIZING TABLETS AND LENS CUP.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female