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 Problems Bacterial Infection (1735); Scarring (2061); Visual Impairment (2138)

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

It has been reported that the patient got a pseudomonas bacterial infection in the eye from the use of the complaint contact lenses which led to permanent scarring and "vision loss." no further information can be obtained at this time.

Manufacturer Narrative

H.3., h.6.: the lot number was not provided and the complaint sample was not made available for evaluation.A trend investigation conducted for the reported lens brand revealed no adverse trends; therefore, no further activities and no further actions are required.A risk based approach to the review of this complaint has been completed.Utilizing the results of this review, (including the criticality level of this complaint, reportability determination, availability of the complaint product, lot code information, and results of the complaint trend analysis) it is determined the applicable manufacturing review level has been completed in accordance with applicable sop(s).No additional investigation is required, at this time.Based on the risk based approach to complaint management the reported events have been assessed as low risk, per procedure.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: 9910480
• MDR Text Key: 188836555
• Report Number: 1065835-2020-00005
• 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: other
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other