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

Catalog Number	0065035821
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Codes	Corneal Ulcer (1796); Keratitis (1944); Red Eye(s) (2038); Blurred Vision (2137); Discomfort (2330); Eye Burn (2523); Eye Pain (4467); Photophobia (4801); Eye Irritation (4803)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As initially the reported by the consumer stating that the consumer experienced serious eye injury caused by the contact lens solution even after following all instruction and neutralizing.The customer suffered a chemical burn to the eye, which led to a ruptured and one mm marginal corneal ulcer in the left eye.The injury required multiple doctor visits, prescriptions for antibiotic and steroid eye drops, and weeks without being able to wear contact lenses.Customer had to wear glasses, which impacted the vision.The contact lens care suddenly stopped neutralizing properly which resulted in vision problem in one eye.The injury had resulted in blurry vision in the affected eye along with discomfort event after medical treatment.During follow up it was also diagnosed to have corneal keratitis.The current status of the consumer's eye is symptom resolved and the customer has resumed contact lens wear.No additional information has been requested.
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
In the follow up, medical records were received which stated that the consumer experienced redness, irritation, eye hurt and increased light sensitivity.Upon slit lamp examination, during staining, more than 50% cornea got stained and was observed one mm round sei with overlying staining superior mid-peripheral cornea in the left eye.Consumer was prescribed with polymyxin b four to five drops for five days and tobramycin dexamethasone qid for five days.Consumer revisited the physician after a week and was observed via slit lamp a complete re-epithelialization with mild stromal swelling in the left eye.The physician discontinued the medicines and was advised to discontinue contact lenses and then slowly build up contact lens use after five days.The current status of the consumer's eye is symptom resolved and the customer has resumed contact lens wear.No additional information has been requested.
Additional Manufacturer Narrative
B3.,b5.,b6.,d9.,h6.,; new information has ben received and additional information has been updated.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
H.3., h.6.: the complaint product was returned for evaluation and was found to meet manufacturing specifications.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: AOSEPT PLUS/CLEAR CARE 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: 22573552
• Report Number: 1610287-2025-00021
• Device Sequence Number: 9700341
• Product Code: LPN
• UDI-Device Identifier: 00047113609027
• UDI-Public: (01)00047113609027(17)251231(11)240111(10)12ALW
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K031521
• 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): 10/14/2025

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: 12/31/2025
• Device Catalogue Number: 0065035821
• Device Lot Number: 12ALW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 09/29/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/08/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NO
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female