MAUDE Adverse Event Report: PRO CLEAR CONTACT; LENSES, SELF CONTACT, DAILY WEAR

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2017

Event Type  malfunction  

Event Description

Pro clear contacts, everyone of the contacts i opened were torn and couldn't use them, a 6 month supply cost me (b)(6).

• Brand Name: PRO CLEAR CONTACT
• Type of Device: LENSES, SELF CONTACT, DAILY WEAR
• MDR Report Key: 6710335
• MDR Text Key: 80119033
• Report Number: MW5070939
• 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: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other