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	Use of Device Problem (1670)
Health Effect - Clinical Codes	Corneal Abrasion (1789); Loss of Vision (2139); Distress (2329)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Non-health care professional reported on behalf of a consumer, who experienced severe damage to the pupil, loss of vision in left eye and significant distress after using cleaning and disinfecting solution.The consumer used the expired products.The current status of the consumer's eye is not resolved at the time of this report.Additional information has been requested but not yet received.
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.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: 16730075
• Report Number: 1610287-2023-00013
• Device Sequence Number: 12439924
• Product Code: LPN
• UDI-Device Identifier: 00047113609027
• UDI-Public: 00047113609027
• Combination Product (Y/N): N
• PMA/510(K) Number: K031521
• 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): 06/26/2023

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: 04/30/2020
• Device Catalogue Number: 0065035821
• Device Lot Number: 295661F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE.; AOSEPT PLUS/CLEAR CARE.; CLEAR CARE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown