MAUDE Adverse Event Report: EUCLID VISION CORPORATION EUCLID MAX ORTHOKERATOLOGY CONTACT LENS; LENS, CONTACT (RIGID GAS PERMEABLE), EXTENDED WEAR

Lot Number F2101470 , F2101672

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer intiating investigation since this was the first time the manufacturer was made aware of this situation and the device has not been returned for inspection.A follow-up report will be filled with the investigation details.

Event Description

On 01/03/2023 euclid vision corporation received the medwatch report no.(mw5113998) from fda about a patient allegation pertaining to euclid lenses.This was the first time that the manufacturer was made aware of the situation.An investigation has been opened complaint no.(b)(4).Has been assigned.

Manufacturer Narrative

Manufacturer initiating investigation since this was the first time the manufacturer was made aware of this situation and the device has not been returned for inspection.This follow up report (#01) includes a status update of the investigation.The prescriber physician has been contacted several times about this report and confirmed a follow up appointment with the patient scheduled for (b)(6) 2023.A follow up report will be filled by the manufacturer to include additional details about the findings.

Event Description

On 01/03/2023, euclid vision corporation received the medwatch report no.(mw5113998) from fda about a patient allegation pertaining to euclid lenses.This was the first time that the manufacturer was made aware of the situation.An investigation has been opened complaint no.(b)(4) has been assigned.This follow up report (#1) includes a status update of the investigation.

Manufacturer Narrative

Manufacturer initiating investigation since this was the first time the manufacturer was made aware of this situation and the device has not been returned for inspection.This follow up report (#3 final) includes the final update of the investigation.Lenses were not received for testing.In (b)(6) 2022, during final appointment with the physician, the doctor found that patient vision was back to normal, 20/20 correction in both eyes and patient returned to wearing glasses.The physician did not consider that the device caused the situation.03/10/2023, this report is now closed.

Event Description

On 01/03/2023, euclid vision corporation received the medwatch report no.(mw5113998) from fda about a patient allegation pertaining to euclid lenses.This was the first time that the manufacturer was made aware of the situation.An investigation has been opened complaint no.(b)(4) has been assigned.This follow up report (#3) includes a status update of the investigation.In (b)(6) 2022, the patient went in for a routine annual exam.The patient was still wearing lenses at night and was doing well.The physician did not see any problems.Patient was advised to return for a follow-up in 6 months.On (b)(6) 2022, patient went in for a follow-up exam.The patient presented an infection determined to be caused by an unknown irritation.The patient was advised to stop wearing his lenses and was treated with antibiotics, standard treatment for eye infection.The physician did not believe that the lens was the cause of the infection.On (b)(6) 2023, patient went in for a follow-up with physician.Vision was back to normal, with 20/20 correction in both eyes, which triggered patient to return to wearing glasses.

Event Description

On 01/03/2023, euclid vision corporation received the medwatch report no.(mw5113998) from fda about a patient allegation pertaining to euclid lenses.This was the first time that the manufacturer was made aware of the situation.An investigation has been opened complaint no.(b)(4) has been assigned.This follow up report (#2) includes a status update of the investigation.

Manufacturer Narrative

Manufacturer initiating investigation since this was the first time the manufacturer was made aware of this situation and the device has not been returned for inspection.This follow up report (#2) includes a status update of the investigation.As of date 03/03/2023, the prescriber physician has been contacted  several times about his assesment of the situation but his feedback has not been presented to manufacturer. a follow up report will be filled by the manufacturer to include  additional details about this situation, if any.

• Brand Name: EUCLID MAX ORTHOKERATOLOGY CONTACT LENS
• Type of Device: LENS, CONTACT (RIGID GAS PERMEABLE), EXTENDED WEAR
• Manufacturer (Section D): EUCLID VISION CORPORATION; 45472 holiday drive; suite7; sterling VA 20166
• Manufacturer (Section G): EUCLID VISION CORPORATION; 45472 holiday drive; suite7; sterling 20166
• Manufacturer Contact: sandra freitez ; 45472 holiday drive; suite7; sterling 20166 ; 7034717145
• MDR Report Key: 16135313
• MDR Text Key: 307105815
• Report Number: 3014175039-2023-00001
• Device Sequence Number: 1
• Product Code: MWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2023

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
• Device Lot Number: F2101470 , F2101672
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 01/03/2023; 01/03/2023; 01/03/2023
• Supplement Dates FDA Received: 02/01/2023; 03/03/2023; 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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