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

Model Number PARAGON CRT100

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Keratitis (1944); Visual Impairment (2138)

Event Date 08/01/2019

Event Type  Injury  

Event Description

Patient developed a superficial keratitis in the left eye which was treated with tobradex.There were no complications and the patient's vision has returned to baseline following orthokeratology lens wear.The patient is currently wearing glasses.

• Brand Name: PARAGON CRT100
• Type of Device: ORTHO-K LENS
• Manufacturer (Section D): PARAGON VISION SCIENCES,INC.; 947 e. impala ave.; mesa AZ 85204
• Manufacturer Contact: vimala punsammy ; 947 e. impala ave.; mesa,
• MDR Report Key: 9148211
• MDR Text Key: 166228870
• Report Number: 2020433-2019-00014
• Device Sequence Number: 1
• Product Code: NUU
• Combination Product (y/n): N
• 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: 10/02/2019

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: PARAGON CRT100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2018
• 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: 12 YR