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 Codes	Failure to Disinfect (1175); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Blurred Vision (2137); Burning Sensation (2146); Excessive Tear Production (2235); Eye Burn (2523)
Date of Event	07/16/2024
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 the government agency that the consumer used the eye care solution to clean the contact lenses and experienced burning of both the corneas and blurry vision.Other events were reported stinging and tearing from the left eye.The consumer visited ophthalmologist and treatments were prescribed tobramycin and dexamethasone ophthalmic suspension and contact bandage for left eye and advised to revisit next day.Consumer revisited next day and ophthalmologist removed contact bandage from the left eye and instructed to continue to use the eye drops for a week instilling one drop in both the eyes for every six hours.The current status of the eyes are symptoms were improving at the time of this report.Additional information has been requested but not yet received.Additional information have been received which states that the consumer are not using the product as per the directions and missing with the pre rinsing part mentioned in the direction of use and the current consumer eye condition was resolved.
Additional Manufacturer Narrative
Udi has been updated in d4.
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 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: 20246237
• Report Number: 1610287-2024-00043
• Device Sequence Number: 12585709
• Product Code: LPN
• UDI-Device Identifier: 00300650363402
• UDI-Public: (01)00300650363402(17)250731(11)230830(10)123ER(21)NA
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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: 07/31/2025
• Device Catalogue Number: 0003630040
• Device Lot Number: 123ER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 01/02/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 09/24/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female