MAUDE Adverse Event Report: COOPERVISION INC. BIOFINITY TORIC CONTACT LENS; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Use of Device Problem (1670)

Patient Problem Corneal Ulcer (1796)

Event Date 05/03/2018

Event Type  Injury  

Event Description

Habitual sleeping in prescription contact lenses, which were not approved for such use, caused a corneal ulcer in his left eye.Scars indicate this is not the first event this patient has experienced.Initiated treatment with maxitrol suspension, and patient must return for follow-up in four days before i can approve wear of contact lenses again.

• Brand Name: BIOFINITY TORIC CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): COOPERVISION INC.
• MDR Report Key: 7494051
• MDR Text Key: 107800735
• Report Number: MW5077047
• Device Sequence Number: 0
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR