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.(b)(4).

Event Description

It was reported that the patient experienced irritation after wearing the new contact lenses.The patient visited the eye care professional (ecp) and was diagnosed with corneal ulcer and was instructed for a follow up visit.The patient visited the ecp on (b)(6) 2019 and was diagnosed again with corneal ulcer.The ecp instructed the patient to stop wearing contact lenses (exact time period unknown) and was advised for a follow up visit.The ecp confirmed eye recovery.Further information clarified that the patient was diagnosed with corneal ulcer on (b)(6) 2019 which resolved in (b)(6) 2019.The corneal ulcer recurred on (b)(6) 2019 and was resolved on (b)(6) 2019.Additional information was received on (b)(6) 2019.It was clarified that the patient's contact lens power was -4.50 but at the end of treatment, the power was changed to -4.75.Additional information was received on 02dec2019.It was reported that the eye had recovered.The consumer was prescribed with levofloxacin and a moisture agent.The patient was instructed to suspend contact lens wear.

Manufacturer Narrative

H.3., h.6.: the lot number was not provided and the complaint sample was not made available for evaluation.No adverse trend could be identified, therefore no further activities are required.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: 9493078
• MDR Text Key: 187935837
• Report Number: 1065835-2019-00019
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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 Catalogue Number: CBVUNK00017
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR