MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-10 for FML LIQUIFILM manufactured by Allergan.
[69970037]
I had a laser surgery in my eyes (to correct vision). Its type was prk surgery. I was told to use fml eye drops. After almost a week of use, i noticed severe wrinkles in the bottom and the outer corners of my eyes. I asked the advise of the doctor by phone and he told to continue using the product. Date the person first started taking or using the product: (b)(6) 2017. Date the person stopped taking or using the product: (b)(6) 2017. Do you still have the product in case we need to evaluate yet: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068402 |
| MDR Report Key | 6399084 |
| Date Received | 2017-03-10 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-03-08 |
| Date Added to Maude | 2017-03-13 |
| 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 | FML LIQUIFILM |
| Generic Name | WETTING SOLUTION |
| Product Code | HPX |
| Date Received | 2017-03-10 |
| Lot Number | E79425 |
| Device Expiration Date | 2019-09-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-10 |