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

Catalog Number	0065036252
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Codes	Purulent Discharge (1812); Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Blurred Vision (2137); Excessive Tear Production (2235); Fungal Infection (2419); Eye Burn (2523); Eye Pain (4467)
Date of Event	04/24/2023
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
Initially received from consumer stating that the consumer experienced pus, dry eye, burning, blurry vision, solution smelled different, irritation, tearing, redeyes and eye pain.Fungal infection was the diagnosis and eye drops were taken.Current patient's condition is symptoms continuing.Additional info has been requested.
Additional Manufacturer Narrative
H.3., h.6.: the actual complaint product was not returned for evaluation.Retain samples have been evaluated.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: 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: 17624608
• Report Number: 1610287-2023-00039
• Device Sequence Number: 15283539
• Product Code: LPN
• UDI-Device Identifier: 00300650361040
• UDI-Public: 00300650361040
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2023

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: 05/31/2025
• Device Catalogue Number: 0065036252
• Device Lot Number: 118XE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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
• Patient Age: 41 YR
• Patient Sex: Female