MAUDE Adverse Event Report: PARAGON VISION SCIENCES, INC. I KONE - F60; RGP CONTACT LENS

Lot Number 3441718U & 5041718U

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Blurred Vision (2137); Excessive Tear Production (2235); Caustic/Chemical Burns (2549)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Paragon is the pma holder for fluroperm60, the material used to cut the lens.Valley contax is an authorized lab for paragon.Valley contax made the i kone f-60 lens associated with this incident.

Event Description

Paragon was made aware on february 15, 2021 by valley contax of an incident regarding a lens manufactured from paragon's material, fluoroperm60.A patient that was fitted with a pair of i kone f-60 lens manufactured by valley contax claimed there was a "toxic film" on the lens that caused her injury (severe pain, watering, blurriness and chemical burns).The lenses were dispensed to the patient in (b)(6) 2018, the claimed injuries were reported in october of 2018.The patient was diagnosed with dry eye syndrome, bilaterial, keratocunus since 1992, bilaterial corneal disorder due to contact lens.The patient claims due to her injuries she is now a candidate for a corneal transplant.The patient has pre-existing corneal conditions which is difficult to discern whether the treatment she received was to aid in the pre-existing corneal conditions (keratoconus in both eyes, dry eye syndrome in both eyes) or secondary contact lens wear.All information that were received only indicated the lens had poor wettability.This could be due to an old contact lens (~1 year), at the time of visit the lens was 11 months old.Poor wettability could also be due to improper use of the contact lens disinfection solution, or improper care or handling by the patient.Poor wettability of a contact lens would not cause any damage to a patient's ocular surface or corneal anatomy.Poor wettability could result in patient's discomfort or poor visual optics.

• Brand Name: I KONE - F60
• Type of Device: RGP 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: 11464458
• MDR Text Key: 239718420
• Report Number: 2020433-2021-00018
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/10/2021

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 Lot Number: 3441718U & 5041718U
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2017
• 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 Age: 55 YR