MAUDE Adverse Event Report: PARAGON VISION SCIENCES, INC. PARAGON CRT100 CONTACT LENS

Model Number CRT100

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

Patient Problems Pain (1994); Ulcer (2274)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

The event was reported by the eye care practitioner to paragon.The complaint was investigated by reviewing the device history record which indicated the lens met the release requirements.The lens was not returned for inspection.As indicated, the doctor suggested there was foreign body that may have been trapped under the lens which could have been the caused of the central ulcer.The patient's eye is completely healed and is back to wearing paragon crt100 lens.

Event Description

The patient developed a small central ulcer on her right eye after wearing the lens (b)(6) 2019.The doctor reported there were some linear track marks that may indicate a foreign body was trapped under the lens.The patient also reported there was pain.The ulcer was treated with drops and lens wear was discontinued.When the patient returned on (b)(6) 2019, the ulcer was mostly healed, no loss of vision was reported or recorded.On (b)(6) 2019, the doctor noted the patient's eye has completely healed, there were no epithelial defects and no loss of vision.The patient has resumed lens wear and is doing well in the lenses.

• Brand Name: PARAGON CRT100 CONTACT LENS
• Type of Device: PARAGON CRT
• Manufacturer (Section D): PARAGON VISION SCIENCES, INC.; 947 e. impala ave; mesa AZ 85204 6619
• Manufacturer (Section G): PARAGON VISION SCIENCES; 947 e. impala ave.; mesa AZ 85204 6619
• Manufacturer Contact: vimala punsammy ; 947 e. impala ave.; mesa, AZ 85204-6619 ; 4805077600
• MDR Report Key: 8562988
• MDR Text Key: 143535068
• Report Number: 2020433-2019-00011
• Device Sequence Number: 1
• Product Code: MWL
• 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: 04/29/2019

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: Health Professional
• Device Model Number: CRT100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2019
• 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