MAUDE Adverse Event Report: ALCON AQUA COMFORT PLUS MULTIFOCAL; CONTACT LENS

Lot Number A0495723

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blurred Vision (2137)

Event Date 08/04/2017

Event Type  malfunction  

Event Description

Opened a new box of alcon dailies aqua comfort plus (multifocal) lenses that i have been using for more than 1 1/2 years.It was immediately apparent that the lens was "floppy" compared to my usual lenses.I then inserted it in my eye and the vision was completely blurred.I opened a second lens with the same result.Called alcon, was placed on hold for 55 minutes and finally in response to a prompt left my name, phone number and description of the problem.No one called me.I called back and after being on hold for 35 min, finally spoke with an insolent, curt and unfriendly woman who offered to send me new lenses after i returned my existing, arranged for my prescription to be forwarded to them, etc.Terrible, customer service with no apparent concern for my problem of having no lenses.

• Brand Name: AQUA COMFORT PLUS MULTIFOCAL
• Type of Device: CONTACT LENS
• Manufacturer (Section D): ALCON
• MDR Report Key: 6776788
• MDR Text Key: 82452287
• Report Number: MW5071453
• 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: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Lot Number: A0495723
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 73