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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR

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ALCON RESEARCH, LLC DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92001362
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Erosion (1750)
Event Date 11/20/2021
Event Type  Injury  
Event Description
A consumer reported experiencing ¿light corneal erosion¿ in an eye a day after removing a torn lens from the eye. The consumer informed that part of the torn lens stayed in the eye and it was difficult to remove. Additional information has been requested for this event, however, not yet received.
 
Manufacturer Narrative
The complaint sample has not returned for evaluation; the lot number is unknown. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
 
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Brand NameDAILIES AQUACOMFORT PLUS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ALCON RESEARCH, LLC
11440 johns creek parkway
duluth GA 30097
Manufacturer (Section G)
ALCON RESEARCH, LLC
11440 johns creek parkway
duluth GA 30097
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key12924209
MDR Text Key281672823
Report Number1065835-2021-00007
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K072777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92001362
Device Lot NumberA0627895
Was Device Available for Evaluation? No
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/03/2021 Patient Sequence Number: 1
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