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	Conjunctivitis (1784); Foreign Body Sensation in Eye (1869); Headache (1880); Hemorrhage/Blood Loss/Bleeding (1888); Rash (2033); Fungal Infection (2419); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2023
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
As initially reported by healthcare professional, the consumer after using opti-free pure moist solution, experienced eye pain, irritation, congestion, nose bleed and sinus headache.The consumer visited a physician and initially thought it to be seasonal allergies.The consumer later found out a nasty moldy smell from the contact lens care solution.In the follow up, the consumer stated that she experienced eye infection and sinus infections.The infection had to be treated with anti- fungal, which caused rashes.Symptoms resolution is unknown.Additional information has been requested but not yet available.
Event or Problem Description
On 30/nov/2023, additional information has been received states that consumer was treated with moxifloxacin 0.5%, 3ml ophthalmic solution and prednisone 1% 15ml ophthalmic suspension eye drops for the eye infection.Additionally, the consumer was treated with prednisone 20mg tablets, ketoconazole 2% shampoo 120ml, ciprofloxacin 500mg tablet, and triamcinolone 0.1% ointment 80gm for sinus and skin rashes.The current condition of consumer's eye is symptoms resolved, with the available information the case still retain as serious and reportable.
Additional Manufacturer Narrative
E2402- appropriate clinical signs, symptoms, conditions term / code not available is not applicable.The actual complaint product was not returned for evaluation.A retained sample from the other 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: 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: 18065296
• Report Number: 1610287-2023-00047
• Device Sequence Number: 12683756
• Product Code: LPN
• UDI-Device Identifier: 00300650361040
• UDI-Public: 00300650361040
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: 118XF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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: CORRECTION
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CIPROFLOXACIN; FAMOTIDINE; FLUTICASONE; KETOCONAZOLE; VITAMIN D2
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female