MAUDE Adverse Event Report: COOPERVISION INC. PROCLEAR TORIC, +0.75-2.25X30 8.4/14.4 UNK ; LENSES, SELF CONTACT, DAILY WEAR

Lot Number 10336500009503

Device Problem Torn Material (3024)

Patient Problem Failure of Implant (1924)

Event Date 05/18/2018

Event Type  Injury  

Event Description

Two contact lenses tore while on her eye causing her to visit her dr's office to have the pieces removed.

• Brand Name: PROCLEAR TORIC, +0.75-2.25X30 8.4/14.4 UNK
• Type of Device: LENSES, SELF CONTACT, DAILY WEAR
• Manufacturer (Section D): COOPERVISION INC. ; scottsville NY 14546
• MDR Report Key: 7650221
• MDR Text Key: 112867449
• Report Number: MW5078145
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/30/2020
• Device Lot Number: 10336500009503
• 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): Required Intervention
• Patient Age: 41 YR