MAUDE Adverse Event Report: COOPERVISION, INC. PROCLEAR MULTIFOCAL CONTACT LENS (OMALFICON B); LENSES, SOFT CONTACT, DAILY WEAR

Lot Number (10) 16733500055010

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Foreign Body Sensation in Eye (1869); Visual Impairment (2138)

Event Date 06/05/2023

Event Type  Injury  

Event Description

Contact lens (normally 30-day wear) became itchy and unwearable after 6 days.The second lens from the same box had the same issue, itchy, gritty, foreign body sensation after just a couple of days.Both lenses had diminished vision, especially in focusing in the distance.I have been using this brand of contact lenses with the same prescription for a number of years, and these lenses were definitely different.They didn't feel right, and my vision was definitely different.The box design was different than previous ones, and they were made in a different country than previous boxes of lenses.Reference report: mw5118278.

• Brand Name: PROCLEAR MULTIFOCAL CONTACT LENS (OMALFICON B)
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): COOPERVISION, INC.
• MDR Report Key: 17097832
• MDR Text Key: 316887828
• Report Number: MW5118279
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: (10) 16733500055010
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White