MAUDE Adverse Event Report: ALCON RESEARCH, LLC OPTI-FREE PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Catalog Number	0003610253
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Keratitis (1944); Red Eye(s) (2038); Burning Sensation (2146); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Photophobia (4801); Eye Irritation (4803)
Date of Event	11/18/2025
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 consumer stating that the consumer started experienced burning, eye pain approximately two weeks before consumer went to primary care provider as well as eye doctor, at first, they thought that it was due to contact lens, as it was approaching the one-month time frame and used new contacts with no improvement.The infection was so severe that the consumer had extreme light sensitivity and migraines.The consumer sought medical intervention and diagnosed with keratitis.The consumer was prescribed with unspecified steroid eye drops.The current status of the consumer¿s eye was symptoms improving at the time of this report.Additional information has been requested but not yet received.Additional information received stating that consumer also experienced red eye, two weeks after doctor visit and treatment with steroid eye drop the consumer tried to wear a brand-new pair of contacts which went well the first day, however after soaking overnight in the solution the consumer's eye was irritated.The consumer stopped using the solution.After changing the solution, the consumer was able to wear contacts but not for a full day as before.The current status of the consumer¿s eye was symptoms resolved at the time of this report.
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.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.No complaint or manufacturing trend was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: OPTI-FREE PUREMOIST MULTI-PURPOSE 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: 24034053
• Report Number: 1610287-2026-00001
• Device Sequence Number: 9296511
• Product Code: LPN
• UDI-Device Identifier: 00300650361057
• UDI-Public: (01)00300650361057(17)280331(11)250414(10)12UW7
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K102860
• 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): 03/03/2026

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: 0003610253
• Device Lot Number: 12UW7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/03/2026
• Date Device Manufactured: 04/14/2025
• 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: Required Intervention; Other
• Patient Age: 36 YR
• Patient Sex: Male