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 Foreign Body Sensation in Eye (1869); Hemorrhage/Bleeding (1888); Eye Burn (2523)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Date of event: unknown, information not provided.Lot number: unknown, not provided.Expiration date: unknown, as lot number was not provided.Device manufacture date: unknown, as lot number was not provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

A report was received that a female consumer used oxysept 1step product, and reported that her eye started to burn, blister and bleed.She immediately sought medical attention and was treated for burns.Local anesthesia had to be used to remove the contact lens from her eye.The consumer returned the next day for examination.Her eyes were in poor quality, and she felt foreign body sensation.Through follow-up it was learned that the product was not used per the instructions for use.The following medications were prescribed, chloramphenicol 1.0% eye ointment for 3 days, prednisolone sodium phosphate 0.5% one drop 4x a day for one week, carmellose eye drops 0.5%, to be used one drop every two hours for 10 days, and (name is not readable) one drop 4x a day for one week.The doctor commented that although the product was not used correctly, the reaction should not have been so severe.No further information was provided.

Manufacturer Narrative

Additional information: through follow-up further information was provided confirming the customer misused the product thinking it was an all in one solution like others she has used in the past.The solution was used the lenses then they were directly inserted into the customers eye.The customer has admitted her error but was advised by the physician to report with the supplier as he believes the reaction the customer suffered was excessive even using the product incorrectly.The product lot number was provided, therefore the following fields have been updated accordingly; lot#: ze04470, udi: (b)(4), expiration date: 11/15/2021.Device manufacture date: 11/6/2018.Device evaluation: product testing could not be performed as the product was not returned.The consumer¿s reported event could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Complaint data was trended in previous 12 months by the product family with the criteria: manufacturing site: amo hangzhou; product type: hydrogen peroxide; other (patient treatment code): eyedrops.Search result: only the objective complaint was reported for the same/similar issue in previous 12 months.Conclusion: based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: device available for evaluation, yes.Returned to manufacturer on, 02/25/2020.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.A chemical test was performed to the returned sample, and all the tested items met product specifications.No product deficiency was identified.As the product was received method code has now been updated from 4114 which was provided in follow-up report #1 to 10.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

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.

• 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: 9584397
• MDR Text Key: 174807500
• Report Number: 3004178847-2020-00002
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• 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,distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/05/2021
• Device Model Number: 07167X
• Device Lot Number: ZE04470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 02/10/2020; 03/11/2020; 10/25/2020
• Supplement Dates FDA Received: 03/09/2020; 04/07/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention