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

Catalog Number CBVUNK00017

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Ulcer (1796)

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

As initially reported by a sales representative via telephone on (b)(6) 2021 on behalf of an doctor who reported that a female patient experienced multiple corneal ulcers and after 2 weeks of stop wearing still the ulcers persist.Additional information received on 13jul2021 stated that the doctor did not perform any culture test but recommended her to see ophthalmology.First time it was isolated corneal ulcer, 2nd time it was pectoral cornea and iris corneal ulcer, second time the ulcer was a really big and that was for first time the doctor saw such a big ulcer where there were 3 different ulcers at a time.The problem occurred with right eye, the consumer had this corneal ulcer issue for about 4 to 5 times in a span of 20 years.Still has the symptoms but she is going to a different ophthalmology now for culture screening and further treatment if needed.Symptoms are continuing.Additional info has been requested but not yet available.

Manufacturer Narrative

H3, h6: the lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.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
• MDR Report Key: 12173671
• MDR Text Key: 261709823
• Report Number: 1065835-2021-00002
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00017
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other