MAUDE Adverse Event Report: CONTAMAC SOLUTIONS, INC. NUTRIFILL SCLERAL CONTACT LENS SOLUTION; PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE

Model Number	Nutrifill
Health Effect - Clinical Codes	Corneal Ulcer (1796); Unspecified Infection (1930); Pain (1994); Fungal Infection (2419)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Used nutrifill scleral lens solution.Developed a corneal ulcer of left eye.Stopped using solution when developed severe pain in eye and saw (b)(6), do who referred to a corneal specialist.Saw (b)(6), md at (b)(6) center in (b)(6).Had weekly appointments thru september.Referred to (b)(6) at (b)(6) center.Cultures were taken and revealed an acanthamoeba parasite and a candida tropicalis fungus.In the meantime opened an email from the nutrifill company which stated that the solution (udi) (b)(4), lot foe (the solution lot that i had been using) had been recalled due to causing corneal ulcers.I had no problems with the solution when using the samples that i received when fitted with the scleral lens (by (b)(6), od at (b)(6) in (b)(6)).It wasn't until i started using the solution that i ordered online which was the above udi and lot number that i started having pain within a couple of days and developed the ulcer as stated above.I have been seeing physicians weekly ever since.I have been told that i will need to have a corneal transplant in the future.Fda safety report id# (b)(4).

• Brand Name: NUTRIFILL SCLERAL CONTACT LENS SOLUTION
• Common Device Name: PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE
• Manufacturer (Section D): CONTAMAC SOLUTIONS, INC.
• MDR Report Key: 13178684
• Report Number: MW5106508
• Device Sequence Number: 4667210
• Product Code: MRC
• UDI-Device Identifier: 00850012123002
• UDI-Public: 00850012123002
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

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 Expiration Date: 09/30/2022
• Device Model Number: Nutrifill
• Device Lot Number: FOE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 180 ASPIRIN; AMLODIPINE; ATORVASTATIN; ATROPINE; CHLORHEXIDINE GLUCONATE OPTHALMIC 0.02% SOLUTION; HYDROCHLOROTHIAZIDE; JARDIANCE; LOSARTIN EYES; METFORMIN HCL; MOXIFLOXACIN; POLYHEXAMETHYLENE BIGUANIDE OPTHALMIC 0.02% SOLUTION; POTASSIUM CHLORIDE; TRESIBA; VALTREX; VORICONAZOLE; VORICONAZOLE OPTHALMIC 1% SOLUTION
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White