MAUDE Adverse Event Report: ALCON LABORATORIES, INC. AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ASKU

Device Problem Insufficient Information (3190)

Patient Problems Hyperemia (1904); Hypersensitivity/Allergic reaction (1907); Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.No code available - epithelial loss.The manufacturer internal reference number is: (b)(4).

Event Description

It was reported by an optician that at the beginning of last (b)(6), a consumer went to the emergency room due to intense hyperemia and photophobia.The doctor observed a circular formation in the central part of her cornea that stained with fluorescein.The doctor prescribed antibiotic therapy for a period of one month.During that month, the consumer rarely used contact lenses.On (b)(6) 2015, she went to a contact lens specialist, who observed hyperemia on the scleral surface and serious irritation of the conjunctiva through a slit lamp.Additionally, the limbus and the pupillary hole were lightly colored with fluorescein.The specialist suggested an application of cortisone for a period of three times a day for five days.After two days, the specialist visited the woman again and noticed an improvement in her physiological state.The consumer also has the characteristics of poor lacrimation and she has to regularly use artificial tears and unspecified ophthalmic gels.Additional information has been requested but not yet received.

Manufacturer Narrative

The lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.(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 LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5210017
• MDR Text Key: 30691887
• Report Number: 1610287-2015-00546
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K142284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

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
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR