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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/12/2021

Event Type  Injury  

Event Description

Patient had a peripheral ulcer on os possibly due to foreign substance or scratch on the lens.Patient had no pain, just some photosensitivity in the affected eye.The patient was treated with besivance and lotomax.The patient's eys has completely healed, with no scarring or loss of visual acuity.The paient is back to wearing paragon crt lens.

• Brand Name: PARAGON CRT DUAL AXIS
• Type of Device: ORTHO-K 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 ; 4805077600
• MDR Report Key: 11617250
• MDR Text Key: 243899820
• Report Number: 2020433-2021-00019
• 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: health professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/30/2021

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: 03/12/2021
• Initial Date FDA Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2020
• 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