MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2020-01-13 for OXYSEPT 1 STEP 07167X manufactured by Johnson & Johnson Surgical Vision, Inc..
[174807500]
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.
Patient Sequence No: 1, Text Type: N, H10
[174807501]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004178847-2020-00002 |
| MDR Report Key | 9584397 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2020-01-13 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-11-18 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SOMYATA NAGPAL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Street | 4TH AVE HZ ECON/TECH DEVELOP. ZONE |
| Manufacturer City | HANGZHOU 310018 |
| Manufacturer Country | CN |
| Manufacturer Postal Code | 310018 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYSEPT 1 STEP |
| Generic Name | SOLUTIONS |
| Product Code | LPN |
| Date Received | 2020-01-13 |
| Model Number | 07167X |
| Lot Number | ZE04470 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705 |
| Product Code | --- |
| Date Received | 2020-01-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-13 |