MAUDE Adverse Event Report: PARAGON VISION SCIENCES, INC. PARAGON CRT100; ORTHO-K CONTACT LENS

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Corneal Scar (1793); Pain (1994); Corneal Infiltrates (2231)

Event Date 01/01/2021

Event Type  Injury  

Event Description

The patient was fitting with paragon crt100 lens on (b)(6) 2019 and completed all follow ups until his annual.His father stated due to covid-19, he forgot about the annual follow up.When the patient was seen in (b)(6) 2021, he had pain in his right eye and some white residue was noticed on the lens.The lens was about 1.5 years old.The cornea looked to have infiltrates per the doctor.The patient was treated with retainer and tobradex.The right cornea improved about 50% but there was still a flat white faint scar after a month of treatment.His bcva is 20/40.The doctor suspected the white reside is from the cleaning solution with chlorhexistine preservative.Paragon crt100 wear has been permanently discontinued.

• Brand Name: PARAGON CRT100
• Type of Device: ORTHO-K CONTACT LENS
• Manufacturer (Section D): PARAGON VISION SCIENCES, INC.; 2120 w. guadalupe rd.; gilbert AZ 85233
• Manufacturer (Section G): PARAGON VISION SCIENCES, INC.; 2120 w. guadalupe rd.; gilbert AZ 85233
• Manufacturer Contact: vimala punsammy ; 2120 w. guadalupe rd.; gilbert, AZ 85233
• MDR Report Key: 12457679
• MDR Text Key: 270996750
• Report Number: 3013398957-2021-00001
• Device Sequence Number: 1
• Product Code: NUU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P870024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 09/10/2021

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 14 YR