ORTHOKERATOTIC CONTACT LENS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-31 for ORTHOKERATOTIC CONTACT LENS manufactured by Euclid Systems Corp.

MAUDE Entry Details

• Report Number: MW5088662
• MDR Report Key: 8855788
• Date Received: 2019-07-31
• Date of Report: 2019-07-30
• Date of Event: 2019-05-21
• Date Added to Maude: 2019-08-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: ORTHOKERATOTIC CONTACT LENS
• Generic Name: LENS, CONTACTS
• Product Code: NUU
• Date Received: 2019-07-31
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: EUCLID SYSTEMS CORP

Device Sequence Number: 1

• Brand Name: ORTHOKERATOTIC CONTACT LENS
• Generic Name: LENS, CONTACTS
• Product Code: MWL
• Date Received: 2019-07-31
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EUCLID SYSTEMS CORP

Device Sequence Number: 2

• Brand Name: ORTHOKERATOTIC CONTACT LENS
• Generic Name: LENS, CONTACTS
• Product Code: MWL
• Date Received: 2019-07-31
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: EUCLID SYSTEMS CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-07-31