MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for TTD EYE CONTACTS - POLAR LIGHTS BLUE, POLAR LIGHTS GREY, PEARL GREY manufactured by Unk.
[174182436]
Severe eye pain and swelling. Post use of ttd eye colored contacts. I developed severe eye pain in both eyes stemming from the posterior areas of eyes. I have difficulty looking left, right, and around. My eyes are also extra sensitive to light. Reason for use: aesthetic contacts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092085 |
| MDR Report Key | 9559481 |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-12-27 |
| Date Added to Maude | 2020-01-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TTD EYE CONTACTS - POLAR LIGHTS BLUE, POLAR LIGHTS GREY, PEARL GREY |
| Generic Name | LENSES, SOFT CONTACT, DAILY WEAR |
| Product Code | LPL |
| Date Received | 2020-01-06 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Product Code | --- |
| Date Received | 2020-01-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-06 |