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

Catalog Number CRT100

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

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Pain (1994)

Event Date 01/18/2019

Event Type  Injury  

Manufacturer Narrative

The lenses were not returned for inspection.A follow up with the doctor's office indicated the patient is fine and is now wearing soft contact lenses.Since the patient did not want the lenses to be replaced, paragon issued credit for the lenses.A review of the device's dhr found the lens met our release requirements at the time of manufacture.No further action is required since microbial keratitis is a well-known riks when wearing any overnight contact lens.This risk is documented in paragon's labeling.

Event Description

Patient started using paragon crt lenses in (b)(6) 2018.Initially the patient used improper care and handling techniques including solution storage.In (b)(6), the doctor reported the patient had improved the care of the lenses.No ulcer was noted during the (b)(6) doctor's visit.In (b)(6) 2019, the patient complained of pain and the doctor observed a corneal ulcer which required medical intervention with eye drops/antibiotics.The doctor discontinued the patient's wear of paragon crt and the ulcer resulted in a corneal scar.To date, the patient's ocular health is stable, and vision is good and unaffected by the scar.The patient is wearing soft contact lenses.

• Brand Name: PARAGON CRT CONTACT LENS
• Type of Device: ORTHO-K LENS
• Manufacturer (Section D): PARAGON VISION SCIENCES, INC.; 947 e. impala ave; mesa 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: 8602155
• MDR Text Key: 144796194
• Report Number: 2020433-2019-00012
• 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: Other
• Type of Report: Initial
• Report Date: 05/06/2019

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 Catalogue Number: CRT100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention