DAILIES TOTAL MULTIFOCAL CONTACT LENS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for DAILIES TOTAL MULTIFOCAL CONTACT LENS manufactured by Alcon Laboratories, Inc..

Event Text Entries

[183346735] This is the third time this issue occurred with alcon dailies total multifocal contacts over the past year. Specifically, when opening the blister pack (lot # n1161667), exp 07/2022, 2 contacts are stuck together for my right eye. I did not know this until i put them on my eye and could not see. Upon removing them, it was apparent that the contacts were doubled up and separated from each other fairly easily. I reported the first and 3rd occurrence (today was the 3rd time) to alcon. I did not report the second occurrence. They asked me to provide them with the receipt from my purchase and my original prescription from my optometrist in order to get the box replaced. They took down the lot info as well. What was disturbing about how they train their customer service staff, was that she asked me where i purchased my contacts from (i responded, "(b)(6)"). She advised me to stop buying from them because "you can't be sure how the contacts are stored. " i advised her that i work in a regulatory role as a professional, and that this is clearly a mfg issue, not a storage issue. It is alarming that the alcon staff are trained in this way, and seem to be failing to take responsibility for their mfg defects. Since this has occurred on 3 separate occasions over the past year, i am confident that this is a pattern, and i am not the only consumer affected, although i don't know how many people actually report the problem. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093635
MDR Report Key9810897
Date Received2020-03-09
Date of Report2020-03-05
Date of Event2020-03-05
Date Added to Maude2020-03-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDAILIES TOTAL MULTIFOCAL CONTACT LENS
Generic NameLENSES, SOFT CONTACT - DAILY WEAR
Product CodeLPL
Date Received2020-03-09
Lot NumberN1161667
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerALCON LABORATORIES, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-09

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