MAUDE Adverse Event Report: ALCON AIR OPTIX NIGHT AND DAY CONTACT; CONTACT LENSES

Lot Number 31200141

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 08/01/2016

Event Type  Other  

Event Description

Placed a brand new contact lens into my eye and had a significant amount of pain.After washing and cleaning it multiple times, i still had the same issue.I tried putting it in my eye several times.It did not appear to be contaminated.A second contact lens in the box was tried instead and felt fine.This was an air optix night and day lens.

• Brand Name: AIR OPTIX NIGHT AND DAY CONTACT
• Type of Device: CONTACT LENSES
• Manufacturer (Section D): ALCON
• MDR Report Key: 5949089
• MDR Text Key: 54768609
• Report Number: MW5064725
• Device Sequence Number: 1
• Product Code: LPL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2016

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?: No
• Device Operator: No Information
• Device Expiration Date: 08/31/2020
• Device Lot Number: 31200141
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 75