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

Catalog Number	0003610003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Eye Burn (2523); Eye Irritation (4803)
Date of Event	11/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Initially reported by a non-health care professional who experienced chemical burns to the cornea immediately upon use and was unable to see clearly for several days.The consumer required emergency care for two times, and upon follow up with ophthalmologist consumer was diagnosed as bilateral eye irritation.Consumer was prescribed with conjunctival injection, dexamethasone, fluorescein, diphenhydramine, oxycodone hydrochloride, alcaine.The use of the product was discontinued.The current status of the consumer's eye was unknown at the time of this report.Additional information has been requested but not yet received.
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).
Additional Manufacturer Narrative
H.3., h.6.: the actual complaint product was not returned for evaluation.A review of production information, complaint history, and servicing was performed and did not reveal any potential contributing factors to the complaint.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: 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: 20735354
• Report Number: 1610287-2024-00053
• Device Sequence Number: 18331890
• Product Code: LPN
• UDI-Device Identifier: 00300650361033
• UDI-Public: (01)00300650361033(17)261231(11)240126(10)12999
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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 Catalogue Number: 0003610003
• Device Lot Number: 12999
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/20/2025
• Date Device Manufactured: 01/26/2024
• 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
• Patient Age: 62 YR
• Patient Sex: Unknown