MAUDE Adverse Event Report: PARAGON VISION SCIENCES, INC. PARAGON RG-4 CONTACT LENS; ORTHOKERATOLOGY CONTACT LENS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Irritation (1941); Keratitis (1944)

Event Date 07/01/2019

Event Type  Injury  

Event Description

The patient was diagnosed with acanthamoeba keratitis while visiting (b)(6).The patient was initially experiencing irritation in the right eye prior to her trip.Her us practitioner suggested she visits a corneal ophthalmologist for an exam.The patient was not diagnosed with any issue and went to visit (b)(6).During her visit in (b)(6) the irritation continued at which time she was advised by her us eye care practitioner to visit a hospital.The patient was diagnosed with acanthamoeba keratitis and treated in (b)(6).The us practitioner stated the patient was not compliant with proper lens insertion and removal techniques including hygiene.The patient has returned to school and will be visiting (b)(6) for a follow up.

• Brand Name: PARAGON RG-4 CONTACT LENS
• Type of Device: ORTHOKERATOLOGY CONTACT LENS
• Manufacturer (Section D): PARAGON VISION SCIENCES, INC.; 947 e. impala ave.; mesa AZ 85204
• Manufacturer (Section G): PARAGON VISION SCIENCES, INC.; 947 e. impala ave.; mesa AZ 85204
• Manufacturer Contact: vimala punsammy ; 947 e. impala ave.; mesa, AZ 85204 ; 4805077600
• MDR Report Key: 9395173
• MDR Text Key: 168642905
• Report Number: 2020433-2019-00015
• 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: 11/30/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 14 YR