MAUDE Adverse Event Report: TWO TOWER FRAMES, INC. CONTACT LENS

Model Number OASYS

Device Problem Shelf Life Exceeded (1567)

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

Event Date 02/20/2018

Event Type  No Answer Provided  

Event Description

On tuesday, (b)(6) 2018, (b)(6) appt 9:30 decided i wanted contact lenses.I put them in and kept the packages they came out of.I came home looking over the packages and realized they were expired.She gave me two different kinds, acuvue dated (b)(6) 2015 and comfilcon dated (b)(6) 2012.I was very unhappy with that.I feel as though it can cause serious damage to my eyes.

• Brand Name: CONTACT LENS
• Type of Device: CONTACT LENS
• Manufacturer (Section D): TWO TOWER FRAMES, INC.
• MDR Report Key: 7295954
• MDR Text Key: 101062544
• Report Number: MW5075517
• Device Sequence Number: 0
• 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: 02/22/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Device Operator: No Information
• Device Model Number: OASYS
• Device Lot Number: 4494550016
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 104