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

Catalog Number CBV92001362

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Tingling (2171)

Event Date 12/22/2017

Event Type  Injury  

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).

Event Description

As initially reported by an (b)(6) via website on 01nov2020, it was stated that on an unknown date consumer bought lenses from optometrist over two years ago and had never been able to wear them properly.The lenses dry out in eyes considerably and had a tingling sensation while wearing them.The consumer made up a mind not to wear them anymore when damaged cornea by put on the contact lens.Consumer underwent an emergency photorefractive keratectomy.Symptoms resolution was unknown.Additional info has been requested but not yet available.Additional information received on 23nov2020, states on (b)(6) 2017, female consumer complaint of lenses drying her eye so much that she had to remove and felt burning sensation in the right eye.Eventually, lenses torn in the eye and consumer was diagnosed with recurrent corneal abrasion of the eye that lead to recurrent erosion.On (b)(6) 2019, consumer underwent emergent photorefractive keratectomy.Post-surgery, consumer states no pain attacks were experienced however consumer continues to have tenderness in the eye when in sun.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

H3, h6: the actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.A trend related investigation was performed; no trend could be identified.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).

Manufacturer Narrative

G3: supplemental medical device report (smdr) #3 is being filed to correct the g3 date on the initial/supplemental report, filed earlier.Incorrect date of 23-nov-2020 05:31 pm is being corrected to 01-nov-2020 02:10 am.The manufacturer internal reference number is: (b)(4).

• Brand Name: DAILIES AQUACOMFORT PLUS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON RESEARCH, LLC; 11440 johns creek parkway; duluth GA 30097
• MDR Report Key: 10964613
• MDR Text Key: 220223300
• Report Number: 1065835-2020-00016
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: CBV92001362
• Device Lot Number: A0511513
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention