MAUDE Adverse Event Report: COOPERVISION, INC. SOFMED BREATHABLES XW TORIC; LENSES, SOFT CONTACT, EXTENDED WEAR

Lot Number 128401700060260023

Patient Problem Corneal Scar (1793)

Event Date 08/07/2023

Event Type  Injury  

Event Description

Contact lens related central corneal ulcer that resulted in corneal scar.

• Brand Name: SOFMED BREATHABLES XW TORIC
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): COOPERVISION, INC.
• MDR Report Key: 18122409
• MDR Text Key: 328116935
• Report Number: MW5148050
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2023

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 Expiration Date: 02/29/2024
• Device Lot Number: 128401700060260023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White