MAUDE Adverse Event Report: ALCON RESEARCH, LLC AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Catalog Number ALCUNK00718

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

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Burning Sensation (2146)

Event Date 05/01/2019

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 was reported that since (b)(6), the consumer suffered eye infection after eye infection and recently the consumer had a corneal ulcer in the left eye (os).The consumer reportedly was not able to wear contact lenses in over a month.The consumer added that she also experienced burning pain when putting the contact lenses in the eye after using the complaint contact lens care solution.The symptom resolution as well as treatment provided were unknown.

Manufacturer Narrative

H.3., h.6.: no lot code or sample was provided by the customer.All lens care products undergo microbial and chemistry in process and finished product testing.All compounding and filling mbrs are subjected to 2 independent reviews.In addition, prior to product release, the following are reviewed: all chemistry and microbial finished product results, environmental, utility records and sanitization records.All products are compounded in the company facility using a stationary stainless steel mix tank.The sterilization of the product is achieved by in-line filtration using sterilizing membrane filters.Filling is performed in a grade a area (class 100).As part of the mbr review, all filter integrity tests are confirmed to be acceptable.Filling areas are routinely monitored for environmental (temperature, humidity, air pressure, viable and non viable particulates).The primary components (bottles and closures) are produced under controlled conditions and are double bagged and placed into shippers from the supplier.The shippers and the components inside are sterilized prior to being sent to alcon.The incoming components are evaluated to ensure that all key attribute, dimensional, and sterilization requirements are met prior to disposition.Root cause of the complaint condition could not be determined; the lot was not provided.Potential root causes that could be associated with the complaint condition include: off label use, (cannot be confirmed), poor lens care practice, (cannot be confirmed), product contamination due to production environment, (unlikely due to the process controls in place), and component sterilization (unlikely, all incoming inspection results were found to be acceptable).Customer product use and storage practice could not be confirmed.No further action is warranted at this time.Lot specific evaluation is not possible without a lot code.The manufacturer internal reference number is: (b)(4).

• Brand Name: AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND 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: 9170457
• MDR Text Key: 162648448
• Report Number: 1610287-2019-00030
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: K142284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ALCUNK00718
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other