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 Patient-Device Incompatibility (2682)

Patient Problems Corneal Abrasion (1789); Corneal Ulcer (1796); Erythema (1840); Foreign Body Sensation in Eye (1869); Headache (1880); Nausea (1970); Pain (1994); Increased Sensitivity (2065); Swelling (2091); Dizziness (2194); Weight Changes (2607)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation; the lot number is unknown.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.(b)(4).

Event Description

A female patient reported via telephone on 11jul2018 that the her previous use of the solution had caused to have ulcers and abrasion in her eyes in 2017.Additional information was received via faxed medical records on 30jul2018.On (b)(6) 2017, the patient went to a health care facility and presented with eye problem and severe right eye pain that woke her from sleep.She was very sensitive to light.The patient wore contacts due to change that day.Upon assessment in the eyes, she was positive for photophobia, pain, redness and her right conjunctiva was injected as well as her left conjunctiva.In the slit lamp examination, the right eye showed corneal ulcer and fluorescein uptake and the left eye shows corneal abrasion and fluorescein uptake.The patient was assessed with possible abrasion vs ulcer in the left eye and was diagnosed with corneal ulcer in her right eye.The eye care provider had prescribed her to start on ofloxacin ophthalmic with urgent ophthalmology follow up.On the same day, the patient was referred to a health care facility which specialized for the eyes for possible ulcer in both eyes.The patient reported nausea with burning and decline in vision on both eyes.She admitted to possible contact lens over wear, used clear care cleaning solution and soaked the lenses nightly for more than six hours.The patient noticed hazy vision in the right eye while wearing the lens on (b)(6) 2017.She attempted putting in a new pair of contact lenses the night prior to the visit but she was not able to do it due to intense foreign body sensation felt in the upper eyelids.During hour of sleep, the patient suddenly woke up with sharp shooting pain and was evaluated in the hospital.The patient had corneal ulcer in the past, had the usual childhood illnesses of mumps, measles and chickenpox and had a cholecystectomy.The patient was taking adderall 20 mg, ofloxacin 0.3% one drop as directed in both eyes every half hour.The patient's body systems were checked and was found to have weight gain, headaches, attention deficit hyperactivity disorder (adhd) and environmental allergies.The patient's right eye was wearing -7.00 +0.50 x 180 and her left eye was -7.25 +0.25 x 070 with corrected visual acuity of 20/200+.The pressure in the right eye was checked was seen with applanation with fluress as well as her left eye.The pressures in the right eye was 15 temporally and the left was 16 temporally.An external eye examination was also done and found out that the lid in her right eye was with swollen rul and her left eye was with swollen lul not inverted for inspection.Anterior segment examination was performed and found that the conjunctiva of her right eye had mild injection as well as her left eye.Her cornea in the right eye had four millimeter area of circular epithelial defects without infiltrate while the left eye had two millimeter irregular staining centrally without infiltrate.The patient was diagnosed with corneal abrasion of both eyes due to contact lens and was prescribed with gabapentin 100 milligrams two tablets four times a day by mouth.The patient was advised to continue with ofloxacin every hour while awake, to start oral gabapentin for comfort, lots of lubrication for comfort and healing and to stop contact lens wear.The patient was scheduled for a follow up check the next day.On (b)(6) 2017, the patient had a follow up visit for corneal abrasion in both eyes.The patient eyes were feeling better but felt occipital stabbing in the left eye (os).Her left eye visual acuity had improved and still felt light sensitivity, causing nausea and feeling dizzy while her right eye (od) visual acuity was still blurry.Her medications were gabapentin 100 mg two tablets four times a day by mouth and ofloxacin 0.3% one drop as directed in both eyes hourly.The patient's right eye pinhole was 20/40 with correct visual acuity of 20/100 and her left eye of 20/25.The patient's left and right lid were still swollen.During the anterior segment examination, it showed that the cornea in her right eye had epithelial defects closed with irregular surface as well as the cornea in her left eye.The patient was prescribed with prednisolone acetate one percent one drop twice a day in both eyes.The patient was advised to decrease ofloxacin to twice a day and start prednisolone twice a day with lots of artificial tears.The patient was scheduled for a follow up visit the following week.On (b)(6) 2017, the patient was in for a follow up check on her both eyes for the corneal abrasion.The patient stated that the visual acuity of both eyes had improved and was doing much better.The patient was taking up ofloxacin 0.3% one drop twice a day in both eyes, prednisolone acetate one percent one drop twice a day in both eyes and systane gel 0.4-0.3% one drop as directed in both eyes.The patient's right eye had corrected visual acuity of 20/20 -2 while her left eye had 20/20.The pressure in the right eye was checked was seen with applanation with fluress as well as her left eye.The pressures in the right eye was 19 and the left was 18.The patient was advised to discontinue drops and to ease back into lenses as the corneal abrasion in both eyes was resolved.

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.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 LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 7757779
• MDR Text Key: 116270482
• Report Number: 1610287-2018-00031
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: K142284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• 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
• Event Location: Home
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 99