MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. OXYSEPT 1-STEP; SOLUTIONS

Model Number 07167X

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

Patient Problems Irritation (1941); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

Age/ date of birth: unknown, information not provided.Date of event: exact date unknown, information not provided.Incident date provided only as (b)(6) 2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

A consumer reported that his eyes were hurting upon insertion of contact lenses after using oxysept 1-step solution.After removal of the contacts, his eyes were red.The consumer was examined by a physician and was diagnosed with irritated eyes due to using oxysept 1-step solution.The consumer was prescribed an eyedrop medication, name of the medication was not provided.The consumer has used this brand of product for a few years and followed the directions for use.The product was first opened in (b)(6) 2020 and incident date is noted as (b)(6) 2020.Additionally, the consumer has not had lasik surgery, does not have allergies and is not a smoker.The consumer has recovered.No further information has been provided.This report captures the event for the solution.A separate report is being submitted for the neutralizing tablets.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

Manufacturer Narrative

Additional information: section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 06/14/2020.Section h3: device returned to manufacturer: yes.Device evaluation: one bottle was returned and chemical test was performed.All the testing results were within the product specification, no product deficiency was identified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.Complaint data was trended in previous 12 months by the reported lot number: ze07848; search result: only the objective complaint was reported in previous 12 months.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: OXYSEPT 1-STEP
• Type of Device: SOLUTIONS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10182415
• MDR Text Key: 200976798
• Report Number: 3004178847-2020-00011
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(17)221020(10)ZE07848
• Combination Product (y/n): Y
• PMA/PMN Number: P850088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2020
• Device Model Number: 07167X
• Device Lot Number: ZE07848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEUTRALIZING TABLETS LOT # UNKNOWN
• Patient Outcome(s): Required Intervention