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

Catalog Number	0003630040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146); Phototoxicity (2165); Excessive Tear Production (2235); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.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 or Problem Description
A non-healthcare professional reported on behalf of a consumer that the consumer experience lacrimation, sensation of scratch sensation, red eyes, eye pain, discharge, dry eye, blurry vision, burning in both eyes.The consumer visited doctor and diagnosed with phototoxicity.The consumer was prescribed with unspecified antibiotics.The current status of the consumer¿s eye was resolved at the time of this report.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.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
• Common Device Name: 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: 18022377
• Report Number: 1610287-2023-00046
• Device Sequence Number: 6538575
• Product Code: LPN
• UDI-Device Identifier: 00300650363402
• UDI-Public: 00300650363402
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 0003630040
• Device Lot Number: 11UWE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LENS CASE : (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR
• Patient Sex: Female