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	Improper or Incorrect Procedure or Method (2017); Improper Chemical Reaction (2952)
Health Effect - Clinical Codes	Corneal Scar (1793); Red Eye(s) (2038); Blurred Vision (2137); Excessive Tear Production (2235); Eye Burn (2523); Caustic/Chemical Burns (2549); Eye Pain (4467); Eye Irritation (4803)
Date of Event	04/21/2024
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 consumer stating that she burned their right eye even after using the contact lens care solution as per the instructions of the product.Consumer also hurt her right eye, tearing and experienced red eyes for two days due to non-neutralization of contact lens care solution even though lenses were kept in contact lens care solution for ten hours for neutralization.Later during the follow consumer provided further information stating that her right eye does not hurt any more but has blurry vision in the middle of the eye due the previous burn that happened from the contact lens care solution.Consumer again during the other follow up provided the information that there was scarring that is present in her right eye which obstructs her vision.Consumer has scheduled appointment with an eye specialist for the symptoms.The current eye status is symptoms continuing at the time of this report.Additional information cannot be obtained as the consumer does not want to be contacted again.
Additional Manufacturer Narrative
H6: updated (event removed) 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 retained sample from the different lot was tested and was found to meet manufacturing specifications.A trend related investigation was performed; no trend could be identified.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.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: 19603226
• Report Number: 1610287-2024-00030
• Device Sequence Number: 12592145
• Product Code: LPN
• UDI-Device Identifier: 00300650363396
• UDI-Public: (01)00300650363396(17)250731(11)230829(10)121XN(21)NA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2024

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: 0003630039
• Device Lot Number: 121XN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 09/12/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/08/2024; 10/07/2024
• Date Device Manufactured: 08/29/2023
• 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: EVENT REMOVED
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female