MAUDE Adverse Event Report: ALCON RESEARCH, LLC OPTI-FREE PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ASKU

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

Patient Problem Keratitis (1944)

Event Date 11/10/2020

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 regulatory response coordinator via email on 24nov 2020, it was stated that on an unknown date, two patients experienced acanthamoeba keratitis which is uncommon.No medical intervention was required.Symptom resolution was unknown.

Manufacturer Narrative

The previous report submitted for this event contained an error in h.1.¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

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: OPTI-FREE PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 11018884
• MDR Text Key: 221766942
• Report Number: 1610287-2020-00039
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: K102860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other