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

Catalog Number 0003630007

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

Patient Problems Corneal Scar (1793); Foreign Body Sensation in Eye (1869); Keratitis (1944); Blurred Vision (2137); Excessive Tear Production (2235); Eye Burn (2523)

Event Date 07/06/2023

Event Type  Injury  

Event Description

As initially reported by the consumer, she experienced itchy, watery eyes, discomfort, followed by the appearance of a whitish veil for both the eyes after wearing the lens disinfected with the lens care solution.The same symptoms continued for the next day even after following correct directions of disinfection with lens care solution.The consumer visited the doctor and had eye examination which showed visual acuity of right eye was 10/10 and for left eye it was 9/10.It was also observed during examination that there was anterior segment corneal erosion in horizontal line, without infiltrate, paracentral temporal and anterior chamber were calm and deep, no conjunctival hyperemia in both eyes.The consumer was diagnosed with keratitis along with temporary scar.The consumer was prescribed with dacryoserum single dose for seven days, azythromycin with a frequency of one drop morning and evening for three days, vitamin a ointment with a frequency for one application at bedtime for seven days and sodium hyaluronate with a frequency of 1 drop hourly for seven days.The consumer was requested to follow-up in 48 hours and instructed to stop contact lens wear for three weeks.As a follow up consumer visited doctor again after two days for keratitis and had eye examination which showed visual acuity for right eye as 10/10 and for left eye as 9/10 and anterior segment calm, deep anterior chamber, clear cornea, clear lens, some superficial punctate keratitis, altered break-up time in both eyes.The doctor confirmed healing of keratitis after eye examination.The consumer was later prescribed with lacrifluid with a frequency of one drop three times a day in both eyes for twelve months and advised not to use new lenses for a week and to keep a track on lens neutralization time.The status of consumer¿s eyes was symptoms resolved at the time of the report.Additional information has been requested but not yet received.

Manufacturer Narrative

H.3., h.6.: the complaint sample has not returned for evaluation.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).

Manufacturer Narrative

H.3., h.6.: the actual complaint product was returned and investigated.The retained sample was also evaluated.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.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
• Manufacturer (Section G): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17843706
• MDR Text Key: 324591237
• Report Number: 1610287-2023-00044
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0003630007
• Device Lot Number: 11UVP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female