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U.S. Department of Health and Human Services

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

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FCI OPHTHALMICS, INC. FCI PROLONG (LEFT EYE); PLUG, PUNCTUM Back to Search Results
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.Reference report: mw5146803.
 
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Brand Name
FCI PROLONG (LEFT EYE)
Type of Device
PLUG, PUNCTUM
Manufacturer (Section D)
FCI OPHTHALMICS, INC.
MDR Report Key17919842
MDR Text Key325795587
Report NumberMW5146802
Device Sequence Number1
Product Code LZU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/11/2023
Patient Sequence Number1
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