MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-24 for BLINK-N-CLEAN 08772X manufactured by Johnson & Johnson Surgical Vision, Inc..
[188485016]
Age/date of birth: unknown, information not provided. Date of event: exact date unknown, information not provided. Best estimate is between (b)(6) 2019. (b)(4). Device evaluation: the product testing could not be performed as the product was not returned. The reported complaint could not be verified. Manufacturing record review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. A search revealed that no complaint was reported in the previous 12 months. 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.
Patient Sequence No: 1, Text Type: N, H10
[188485017]
Consumer reported that she purchased blink and clean lens drops around (b)(6) but upon using the drops she experienced irritation, tingling and bumps. She stopped using the drops and the symptoms abated. Her doctor prescribed antibiotics and blink lubricating drops for her dry eye and to provide immediate comfort. She tried the blink and clean lens drops again yesterday ((b)(6) 2020) and experienced the same thing plus irritation on the eye lid and the skin around the eye. Her eyes feel better but are still tender. Thru additional follow-up the consumer reiterated that her eyes feel better although there is still discomfort. Additionally, she reported that her eyes are sensitive to? Screens? And light. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004178847-2020-00003 |
| MDR Report Key | 9628992 |
| Report Source | CONSUMER |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 | BLINK-N-CLEAN |
| Generic Name | REWETTERS |
| Product Code | LPN |
| Date Received | 2020-01-24 |
| Model Number | 08772X |
| Lot Number | ZD05433 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2020-01-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-24 |