MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-06 for LASIK manufactured by .
[66930262]
Poor night driving vision as a result of lasik in (b)(6) 2016. Name of the company that makes (or compounds) the product: lasikplus. Date the person first started taking or using the product: (b)(6) 2016. Date the person stopped taking or using the product: (b)(6) 2016. Did the problem stop after the person reduced the dose or stopped taking or using the product: no. Why was the person using this product (such as what condition was it supposed to treat): poor vision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067753 |
| MDR Report Key | 6311727 |
| Date Received | 2017-02-06 |
| Date of Event | 2016-06-24 |
| Date Added to Maude | 2017-02-08 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LASIK |
| Generic Name | LASIK |
| Product Code | OJK |
| Date Received | 2017-02-06 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-06 |