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

Lot Number 29634800058010

Device Problem Insufficient Information (3190)

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

Manufacturer Narrative

No device sample was returned for manufacturer analysis.A lot number was provided for the device alleged to be involved in the incident.Lot history, device history, sterilization records, and trend reporting were reviewed.No issues or nonconformance's were found and no trends were identified.No root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.

Event Description

It was reported by the patients practitioner that the patient had developed a mid-peripheral ulcer while using the device.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 ulcer and unknown patient outcome.

• 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: 12682816
• MDR Text Key: 281287095
• Report Number: 3003981983-2021-00002
• 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: 29634800058010
• 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