MAUDE Adverse Event Report: PARAGON VISION SCIENCES, INC. PARAGON CRT DUAL AXIS; ORTHOKERATOLOGY, CONTACT LENS

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

Patient Problem Corneal Ulcer (1796)

Event Date 01/11/2023

Event Type  Injury  

Event Description

Patient developed mild ulcer in od.The ulcer was located inferior temporal in the treatment zone but outside of the visual axis.The dr prescribed moxifloxacin and discontinued use as of (b)(6) 2023.The patient had decreased visual acuity as a result but the dr expects there to be no permanent damage or altering of the cornea.The dr reported tight edges and reordered lens with flatter lza.The ecp indicated that the cornea had fully healed and their va was back to what it normally was uncorrected.

Manufacturer Narrative

Lens serial number the patient was wearing at the time of the incident: (b)(6).The sales order for that lens was: so00418307 (shipped 12/20/2022).Ecp ordered new lens with flatter lza, so00423689 (shipped 1/13/23).

• Brand Name: PARAGON CRT DUAL AXIS
• Type of Device: ORTHOKERATOLOGY, CONTACT LENS
• Manufacturer (Section D): PARAGON VISION SCIENCES, INC.; 2120 w. guadalupe road; gilbert AZ 85233 2810
• Manufacturer Contact: mrunmayee patil ; 2120 w. guadalupe road,; gilbert, AZ 85233-2810 ; 4808927602
• MDR Report Key: 17347383
• MDR Text Key: 319278801
• Report Number: 3013398957-2023-11926
• 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: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/18/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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