MAUDE Adverse Event Report: ALCON DAILIES 1 TOTAL MULTIFOCAL; LENSES, SOFT CONTACT, DAILY WEAR

Model Number DALIES 1 TOTAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Blurred Vision (2137)

Event Date 01/02/2018

Event Type  malfunction  

Event Description

Below is the email i have sent 2x to alcon the mfr with no response.Over a 3 wk period, i have reported this on their product issue website.I am just interested: is this an issue over more the batches i have experienced; has the issue been dealt with; is there any degradation of the lenses in the blisters - ie do they work as expected; is there anyway to screen blisters for double lenses since putting two lenses in one eye causes discomfort.I am currently a user of dailies total 1 multifocals and have recently experienced issues with two batches of lenses purchased in 90 packs; -3.00 hi +2.50, k2lot n1144543, exp 10/20/2020, e51010037.There have been multiple incidents of double lenses being in a pack causing me to discard that blister.Additionally, i have experienced the same issue on one recent batch of -3.25 hi +2.50, but did not retain the blister with the lot number."is there a quality issue with these batches, should i be returning or discarding them." the first couple of events of events of double lenses in the eye caused me to assume, i had no lens due to blurry vision.Update: since i last wrote i have experienced the same duplication with a batch on -3.25 hi +2.5.The lot number is k2lot n1145546, exp 11/20/2020, h25010843.

• Brand Name: DAILIES 1 TOTAL MULTIFOCAL
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON
• MDR Report Key: 7327099
• MDR Text Key: 102102959
• Report Number: MW5075771
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: DALIES 1 TOTAL
• Device Catalogue Number: K2LOT N1145546
• Device Lot Number: H25010843
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1