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

Catalog Number	0003630039
Medical Device Problem Codes	Product Quality Problem (1506); Improper Chemical Reaction (2952); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Burning Sensation (2146); Caustic/Chemical Burns (2549); Eye Irritation (4803)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional 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).
Event or Problem Description
As initially reported by a non-healthcare professional, stating that the consumer experienced repeated chemical burns, eye injury, severe burning, and discomfort after wearing contact lenses in both eyes, despite strictly following all directions for use with the lens care solution.Although the product has been trusted for decades, the consumer stated that recent failures are unacceptable and dangerous, noting that the disc does not function properly and that these issues have disrupted daily activities.The problem occurred multiple times across several cases.At the time of reporting, no medical intervention had been sought.The current status of the consumer¿s eye was symptoms continuing at the time of this report.Additional information has been requested but not yet received.
Event or Problem Description
As initially reported by a non-healthcare professional, stating that the consumer experienced repeated chemical burns, eye injury, severe burning, and discomfort after wearing contact lenses in both eyes, despite strictly following all directions for use with the lens care solution.Although the product has been trusted for decades, the consumer stated that recent failures are unacceptable and dangerous, noting that the disc does not function properly and that these issues have disrupted daily activities.The problem occurred multiple times across several cases.At the time of reporting, no medical intervention had been sought.The current status of the consumer¿s eye was symptoms continuing at the time of this report.Additional information has been requested but not yet received.Upon follow up information it was reported that consumer experienced issues after the change in the new lens case design.
Additional Manufacturer Narrative
The manufacturer internal reference number is:(b)(4).
Additional Manufacturer Narrative
H.3., h.6.: 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.A trend related investigation was performed; no trend could be identified.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: 23894751
• Report Number: 1610287-2025-00033
• Device Sequence Number: 5330181
• Product Code: LPN
• UDI-Device Identifier: 00300650363396
• UDI-Public: (01)00300650363396(17)270531(11)250624(10)12W1T
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 02/17/2026

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 Catalogue Number: 0003630039
• Device Lot Number: 12W1T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2025
• Supplement Date Received by Manufacturer: 01/17/2026; 02/06/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/23/2026; 02/17/2026
• Date Device Manufactured: 06/24/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female