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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Abrasion (1789); Corneal Ulcer (1796); Itching Sensation (1943); Red Eye(s) (2038); Blurred Vision (2137); Overwear Syndrome (2234); Eye Burn (2523); Eye Pain (4467)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As initially reported by consumer stating that she put her lenses after soaking them in the solution for one day, experienced foggy vision and the symptom did not resolved after removing contact lenses.After that she experienced excruciating pain and went to emergency department and was diagnosed with bilateral chemical corneal abrasions.Eyes were irrigated.The burns were so bad, they recommended to shift to other hospital for further evaluations.Further information received on 11/dec/2022 states that the consumer went to emergency department with bilateral eye pain associated with photophobia and tearing.The consumer was positive for pain, redness and itching.Fluorescein test was done on both eyes resulting in approximately 5 to 6 mm over the central visual field for right eye.Consumer was diagnosed with bilateral corneal abrasions and corneal ulcer.Bilateral eye irrigations were done and discharged with antibiotics.Erythromycin 5 mg/gm ophthalmic ointment, ofloxacin 0.3% ophthalmic drops, albuterol hfa 108 (90 base) mcg/act inhaler, amphetamine/dextroamphetamine 5 and 10 mg tablet, cetirizine 10 mg tablet, loratadine 10 mg tablet, nitrofurantoin macrocrystal 50 mg capsule, erythroid ofloxacin were prescribed.The current status of patient's eye is resolved.
Additional Manufacturer Narrative
The complaint sample has not returned for evaluation.Investigation including root cause analysis is in progress.The manufacturer internal reference number is: (b)(4).
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.A retention sample of the reported complaint batch was submitted and investigated.Testing results were reviewed and found to be acceptable.No root cause was 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: 16069116
• Report Number: 1610287-2022-00081
• Device Sequence Number: 6334142
• Product Code: LPN
• UDI-Device Identifier: 00300650363402
• UDI-Public: 00300650363402
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 12/31/2023
• Device Catalogue Number: 0003630040
• Device Lot Number: 1120Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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: 25 YR
• Patient Sex: Female