MAUDE Adverse Event Report: COOPERVISION LIMITED COOPER VISION PRO CLEAR TORIC; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Crack (1135)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/20/2022

Event Type  Injury  

Event Description

Coopervision proclear toric contact lens.Four lenses with a 30 day daily wear tore in the space of three weeks.Lodging in eye.Looks like a batch problem.Purchased from (b)(6).Fda safety report id # (b)(4).

• Brand Name: COOPER VISION PRO CLEAR TORIC
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): COOPERVISION LIMITED
• MDR Report Key: 13592271
• MDR Text Key: 286259664
• Report Number: MW5107674
• 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: 02/20/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian