MAUDE Adverse Event Report: ALCON RESEARCH, LLC AIR OPTIX NIGHT & DAY; LENSES, SOFT CONTACT, EXTENDED WEAR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Corneal Scar (1793)

Event Date 08/28/2019

Event Type  Injury  

Event Description

Pt presented for eye examination and contact lens fitting.Pt admitted to wearing air optix night and day contact lenses constantly for up to three months, which has kept him from needing an eye exam for three years.Ocular examination revealed corneal neovascularization and multiple corneal scars of which the pt was unaware.The pt was immediately refit into a lens which is not approved for continuous wear, and extra time was spent educating the pt regarding risks of overwear, including lasik complications, and being forced to discontinue wearing contact lenses altogether.Pt agreed to remove lenses every night and throw away as directed.Fda safety report id# (b)(4).

• Brand Name: AIR OPTIX NIGHT & DAY
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): ALCON RESEARCH, LLC; fort worth TX 76134
• MDR Report Key: 8960069
• MDR Text Key: 156563720
• Report Number: MW5089509
• Device Sequence Number: 1
• Product Code: LPM
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 31 YR