MAUDE Adverse Event Report: ALLERGAN FML LIQUIFILM; WETTING SOLUTION

Lot Number	E79425
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: FML LIQUIFILM
• Common Device Name: WETTING SOLUTION
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 6399084
• Report Number: MW5068402
• Device Sequence Number: 14182651
• Product Code: HPX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 09/30/2019
• Device Lot Number: E79425
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Weight: 70