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

Catalog Number CBV92004051

Device Problem Sharp Edges (4013)

Patient Problems Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869)

Event Date 10/15/2021

Event Type  Injury  

Event Description

A consumer reported, ¿experienced several lenses with a sharp edge, and developed a corneal ulcer¿ after contact lens wear in the right eye.The consumer was treated with antibiotic eye drops and the symptoms resolved.The consumer resumed contact lens wear in the right, and experienced ¿a sharp feeling lens¿ in the right eye and removed the lens.Additional information was requested for this event; however, no updates have been received at this time.

Manufacturer Narrative

The complaint sample has not returned for evaluation.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).

Manufacturer Narrative

Additional information updated in a2, b3, b5 h.3., h.6.: the actual complaint product was not returned for evaluation.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received which states that an ulcer occurred on the right medial cornea.Consumer was treated with neomycin, polymyxin b sulfates and dexamethasone ophthalmic suspension from (b)(6) 2021 to (b)(6) 2021.The current status of the consumer eye was recovered.This report of centrally located corneal ulcer, which requires administration of antibiotic eye drops, a serious event, cannot be ruled out at this time of 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
• 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: 12868135
• MDR Text Key: 281202065
• Report Number: 1065835-2021-00006
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: CBV92004051
• Device Lot Number: A5109202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female