• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON RESEARCH, LLC DAILIES TOTAL 1; LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92004051
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Corneal Ulcer (1796); Irritation (1941); Red Eye(s) (2038)
Event Date 11/26/2019
Event Type  Injury  
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.The manufacturer internal reference number is: (b)(4).
 
Event Description
It was reported on 20dec2019 via email that a consumer experienced an irritated, watery, and red right eye on (b)(6) 2019.It was also reported that the eye affected was only the right eye.The consumer sought medical attention on (b)(6) 2019 and was diagnosed with corneal infiltrate/ulcer.The consumer was prescribed with moxifloxacin every two hours for the first two days then tapered to four times a day for five days.It was reported that the symptoms have resolved.
 
Manufacturer Narrative
H.3., h.6.: the actual complaint product was not returned for evaluation.The investigation included a review of the complaint history/trend, manufacturing records, component nonconformance history, nonconformance history, in process sampling/control information, equipment logbook, sterilization, retain sample inspection, and training deviations.There were no deviations that would contribute to the nature of the complaint.The lot met release criteria and is acceptable for continued distribution.Per the sterilization effectiveness memo, due to the sterilization cycle used to produce contact lenses, it can be concluded that any infection of the eye suffered by patients using lenses that have been terminally sterilized and are taken from an intact primary package cannot be the result of any organism originating from that package.There were no nonconformance identified related to sterilization of the complaint lot.In addition, the consumer did not indicate any leaking packages or that there was no saline in any package or any other seal related events, no sealing related defects were identified during any in process inspections of the complaint lot, nor during final inspection of the complaint lot.No root cause was able to be identified based on the manufacturing conditions as all processes were reviewed and found to be within specifications.The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DAILIES TOTAL 1
Type of Device
LENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ALCON RESEARCH, LLC
11440 johns creek parkway
duluth GA 30097
MDR Report Key9568413
MDR Text Key174725556
Report Number1065835-2020-00003
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
K113168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/31/2021
Device Catalogue NumberCBV92004051
Device Lot NumberA5049946
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/20/2019
Initial Date FDA Received01/09/2020
Supplement Dates Manufacturer Received01/24/2020
Supplement Dates FDA Received02/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age40 YR
-
-