MAUDE Adverse Event Report: PARAGON VISION SCIENCES, INC. PARAGON CRT DUAL AXIS; ORTHO-K LENSES

Device Problem Defective Device (2588)

Patient Problem Corneal Scar (1793)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

The lens was not returned, unable to determine root cause of the problem.Unable to determine if the lens was defective or if this adverse event was due to mishandling.

Event Description

The event occured in australia.The patient had a corneal infection during august with central epithelia defect noted.The patient now has a central corneal scar.In the patient's most recent appointment, the patient's right topography seems to have had a central island which was not shown in the earlier appointment in the patient's first month of wear.Her right cornea had a mild cortical staining near the site of corneal scar, there was no peripheral staining.The patient was treated with tobrax, eye drops and told to stop wearing the lenses.The doctor is unsure of the cause of the scar (epithelial defect).

• Brand Name: PARAGON CRT DUAL AXIS
• Type of Device: ORTHO-K LENSES
• 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: 15875255
• MDR Text Key: 304425355
• Report Number: 3013398957-2022-00001
• 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: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/28/2022

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White