MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-07 for CLEAR CARE EYE SOLUTION CASE manufactured by Alcon Research, Ltd..
[132568012]
Clear care, i fell asleep with my contacts in. I woke up in the middle of the night, and put my contacts in the clear care eye solution container as specified, with the proper amount of solution. When i woke up , i put my contacts in, and they immediately started burning. I took them out. I realized that they must not have sat in the contact container for the full six hours. This morning, one day later, my eyes are still red, watering, burning, and my right eye has begun secreting green mucus. I am very unhappy, clear care should make it clear that chemical burns can occur on your eye if contacts do not sit in the container long enough. Medication administered to or used by the patient: no; in my opinion, they do not provide adequate warnings on their package. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082904 |
| MDR Report Key | 8227172 |
| Date Received | 2019-01-07 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-01-01 |
| Date Added to Maude | 2019-01-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLEAR CARE EYE SOLUTION CASE |
| Generic Name | CASE, CONTACT LENS |
| Product Code | LPN |
| Date Received | 2019-01-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. |
| Brand Name | CLEAR CARE EYE SOLUTION CASE |
| Generic Name | CASE, CONTACT LENS |
| Product Code | LRX |
| Date Received | 2019-01-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-07 |