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

Device Problem Product Quality Problem (1506)

Patient Problems Corneal Abrasion (1789); Dry Eye(s) (1814); Vitreous Floaters (1866); Foreign Body Sensation in Eye (1869); Hypersensitivity/Allergic reaction (1907); Keratitis (1944); Red Eye(s) (2038); Blurred Vision (2137); Excessive Tear Production (2235); Eye Burn (2523); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/23/2023

Event Type  Injury  

Event Description

Safety event description: a consumer experienced consumer stating she experienced blurry vision, dry eye, eye pain, lens became hard, red eyes, corneal abrasion, discomfort made nose constantly run and sound sick and tearing.Additional information received with medical record states that the consumer visited doctor and underwent eye examination in which consumer¿s lid margin, anterior chamber, iris, and lens were normal for both eyes.Conjunctiva and cornea were normal for left eye.But in right eye the consumer got diagnosed with central recurrent corneal erosion.The consumer was prescribed with moxifloxacin ophthalmic solution 0.5% with a frequency of every hour while awake, carboxy methyl cellulose sodium eye drops with a frequency of every night at bedtime and systane complete eye drops with a frequency of once in a day in the morning.The consumer was suggested to schedule a follow-up visit.The consumer visits another doctor as a follow-up visit.The consumer again underwent eye examination in which lid margin, anterior chamber, iris, conjunctiva, and lens were normal for both eyes.The diagnostic drops used were fluorescein sodium and benoxinate hydrochloride corneal examination showed abnormal tear breakup time, abnormal tbut (tear break up time) 3 seconds, lasik flap (laser-assisted in situ keratomileusis), positive punctate epithelial erosions and diagnosed with vitreous syneresis in both eyes.The consumer was advised discontinued moxifloxacin prescribed with preservative free artificial tears with a frequency of four times a day and increased dose of omega supplements.The consumer was recommended to apply warm compress to lids once in a day and to increase hydration, sleep hygiene and computer strain with decreased blink rate.The consumer was suggested to follow-up in six weeks.The current status of consumer¿s condition was resolved at the time of report.Additional information has been requested but not yet received.

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).

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history 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
• Type of Device: 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: 17797378
• MDR Text Key: 324007225
• Report Number: 1610287-2023-00041
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0003630040
• Device Lot Number: 11XDD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OMEGA 3
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Female