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

Model Number CRT100

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

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

Manufacturer Narrative

A good faith attempt was made to gain further information regarding the incident, however, pvs was unable to speak with the doctor.The patient ocular health is fine and ready to be refitted with paragon crt.

Event Description

Patient developed a central ulcer that took months to clear.The patient's eye is fine and the doctor is ready to refit the patient for paragon crt lens.

• Brand Name: PARAGON CRT100 CONTACT LENS
• Type of Device: ORTHO-K LENS
• Manufacturer (Section D): PARAGON VISION SCIENCES, INC; 947 e. impala ave.; AZ 85204 6619
• Manufacturer (Section G): PARAGON VISION SCIENCES, INC.; 947 e. impala ave; mesa AZ 85204 6619
• Manufacturer Contact: vimala punsammy ; 947 e. impala ave.; mesa, AZ 85204-6619 ; 4805077600
• MDR Report Key: 8847924
• MDR Text Key: 152911100
• Report Number: 2020433-2019-00013
• 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
• Type of Report: Initial
• Report Date: 07/29/2019

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
• Device Model Number: CRT100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2018
• 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: 10 YR