MAUDE Adverse Event Report: FCI OPHTHALMICS, INC. FCI PROLONG (RIGHT EYE); PLUG, PUNCTUM

Patient Problems Dry Eye(s) (1814); Discomfort (2330)

Event Date 10/02/2023

Event Type  Injury  

Event Description

My opthalmologist put in fci opthalmics 6-week silicone tear duct plugs into both my eyes for dry eye.I was told i shouldn't feel them, but i feel them in there like old contact lenses, and my eyes are still dry, no changes.Went back to md (physician) who said my eyes are ok, i am the first complaint, all his patients who have them never complained, and prescribed antibiotic eye drops.I called the company to ask if i should be feeling them as it's irritating, and if something can be done to dissolve them sooner.The company told me they don't speak to patients, they will ask a rep to call my md and i need to work with my md.I'd just like to know if i'm in danger as this is my eyes and it must have happened before.The plugs are still in my eyes as i was told they cannot be removed but it seems unrealistic to wait 6 weeks for them to dissolve.(b)(6) 2023, md checked eyes for scratches.Reference report: mw5146802.

• Brand Name: FCI PROLONG (RIGHT EYE)
• Type of Device: PLUG, PUNCTUM
• Manufacturer (Section D): FCI OPHTHALMICS, INC.
• MDR Report Key: 17919859
• MDR Text Key: 325795792
• Report Number: MW5146803
• Device Sequence Number: 1
• Product Code: LZU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1