MAUDE Adverse Event Report: ALCON LABORATORIES INC ALCON DAILIES AQUA COMFORT PLUS; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number A0537126

Device Problems Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem Pain (1994)

Event Date 12/13/2018

Event Type  Injury  

Event Description

Product: alcon dailies aqua comfort plus contact lenses lot # a0537126 exp date: 12/31/2022.I have had two separate incidents (on (b)(6) 2018 respectively) where these contact lenses have literally split apart in my right eye immediately after insertion, causing severe pain, and great difficulty in removing.The issue is only with the lenses for my right eye, i have been a contact wearer for over 35 years, and have never incurred this type of situation previously.On a scale of 1-10, with 10 being the highest, the pain was at least a solid 9 on each occasion.I have been wearing this brand of daily wear contact lenses for approximately 5 months.I had purchased a full one year's supply.I have also noticed on multiple occasions that the lenses are supplied "inside out" when i am trying to insert them into my right eye.Again, this is not a problem that i have never encountered before.It makes me question the manufacturing quality of these lenses even further.I have astigmatism in my left eye and wear alcon dailies for astigmatism in that eye.I have never encountered any of the above issues with those lenses.Again, this makes me question alcon's quality within the above referenced lot #.I have notified alcon of these adverse events today.I am awaiting a response.These incidents with the splitting of the contacts while in my eye is extremely troubling, and i am afraid to wear them further until some type of investigation into a possible defect can be performed.I look forward to hearing from you soon.Thank you.

• Brand Name: ALCON DAILIES AQUA COMFORT PLUS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON LABORATORIES INC
• MDR Report Key: 8175334
• MDR Text Key: 130984785
• Report Number: MW5082209
• 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: 12/13/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Lot Number: A0537126
• 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: 122