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

Catalog Number CBV10098344

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Corneal Ulcer (1796); Inflammation (1932); Red Eye(s) (2038); Eye Infections (4466); Eye Pain (4467)

Event Date 03/04/2024

Event Type  Injury  

Event Description

A healthcare professional on behalf of customer reported stating that consumer experienced sore eye and red eye after mistakenly wearing the contact lenses for an extended period (two -three weeks) without removing them.Consumer later consulted optometrist for her symptoms of sore and red eye, corneal inflammation and/or infection.Consumer was diagnosed with corneal ulcer which is non infectious in right eye with less than 50% of corneal surface involvement by the optometrist.Decrease in snellen lines was not noted.The current status of the consumer¿s eye was improving at the time of this report.Additional information has been requested but not yet received.

Manufacturer Narrative

H.3., h.6.: 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).

• 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
• 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 Key: 18959031
• MDR Text Key: 338354475
• Report Number: 1065835-2024-00004
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBV10098344
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female