MAUDE Adverse Event Report: COOPERVISION MANUFACTURING, LTD. MISIGHT 1 DAY (OMAFILCON A)

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

Manufacturer Narrative

No product has been made available for manufacturer analysis and no lot number provided for manufacturer investigation.Given the lack of available device information, the manufacturer is unable to complete further investigations at this time and no root cause can be established.The relationship between the coopervision device and the event is unconfirmed.Should further information become available, the manufacturer will complete further investigations as appropriate and submit a follow-up report as applicable.

Event Description

It was reported by the patients practitioner that the patient had developed an ulcer while using the device.The patient came in for exam in (b)(6) 2021 and the doctor noted a scar from a previous corneal ulcer.The patient had not come in for treatment due to covid concerns.Good faith efforts have been made to obtain further information without success.As of the date of report, additional information is unknown.This event is being reported in an abundance of caution due to unknown size and location of the scar and impact on visual acuity.

• Brand Name: MISIGHT 1 DAY (OMAFILCON A)
• Type of Device: MISIGHT 1 DAY (OMAFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; chandlers ford, erith house; warrior close; eastleigh, hampshire SO53 4TE; UK SO53 4TE
• MDR Report Key: 12682808
• MDR Text Key: 281277910
• Report Number: 3003981983-2021-00001
• Device Sequence Number: 1
• Product Code: MVN
• Combination Product (y/n): N
• PMA/PMN Number: P180035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other