MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-09 for HOLLYWOOD CONTACTS manufactured by .
[4749290]
Patient was able to purchase colored contact lenses without any doctor's contact lens prescription. Patient presented with red eyes. Upon further examination, corneal neovascularization was present in both eyes. Patient was instructed to discontinue use and return to my office in 12 weeks. Contact lenses were obtained without a doctor's prescription from (b)(6). One pair; frequency: daily; ophthalmic. Dates of use: (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037610 |
| MDR Report Key | 3983459 |
| Date Received | 2014-07-09 |
| Date of Report | 2014-07-08 |
| Date of Event | 2014-07-08 |
| Date Added to Maude | 2014-08-07 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLLYWOOD CONTACTS |
| Generic Name | COLORED CONTACT LENS |
| Product Code | LRX |
| Date Received | 2014-07-09 |
| Lot Number | UNK |
| Device Expiration Date | 2014-07-01 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-09 |