MAUDE Adverse Event Report: ALCON LABORATORIES, INC. OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Acanthameba Keratitis (1945); Loss of Vision (2139)

Event Date 06/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

It was reported on 05/31/2017 via email with attached legal petition from the consumer¿s legal representative that the female consumer developed a severe corneal eye infection after using the complaint product.It was added that the complaint product failed to destroy acanthamoeba which caused the development of acanthamoeba keratitis that resulted in the loss of the consumer¿s eye sight in her left eye (os).Additionally, it was reported that the consumer experienced the harm due to inadequate instructions, incorrect representation of the facts and failure to use due care in the design, manufacturing and quality control of the product.No further information is available.

Manufacturer Narrative

(b)(4).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.

Event Description

Additional information was received on 08/16/2017 via medical records.It was reported that the consumer visited an optometrist on 09/18/2015 due to irritation, redness, throbbing, photophobia, matting, pain and swelling which began on (b)(6) 2015.She used an unspecified over the counter (otc) eye drops which did not help and the condition seemed worse.She had stopped wearing contact lenses on (b)(6) 2015.Slit lamp examination revealed old corneal scars and an infiltrate in right eye (od) and severe inflammation with a large corneal infiltrate, endothelial striae and corneal surface erosion, cells were present in the anterior segment in the left eye (os), 3+ injection in the conjunctiva, acanthamoeba keratitis (ak) with perineuritis, corneal haze, scarring in the cornea, os.The consumer was diagnosed with severe keratitis, os and was referred to an ophthalmologist.During the referral visit on (b)(6) 2015, slit lamp examination revealed inactive corneal scarring, both eyes (ou), 0.5 x 0.5 mm corneal ulcer, os and 1+ cell/flare in the anterior chamber, os.The ophthalmologist diagnosed the consumer with corneal ulcer, os-moderate and prescribed moxifloxacin 0.5% ophthalmic solution every hour, os, to start for 24 hours before prednisolone drop and prednisolone acetate 1% ophthalmic suspension, os, four times a day.On (b)(6) 2015, the consumer visited the ophthalmologist for a follow up visit.The consumer reported that she was feeling better but her vision was still very blurry.Her od was still red/irritated and felt like there was an eyelash inside the eye.Slit lamp examination revealed 0.5 x 0.5 mm corneal ulcer os - improving.The consumer was diagnosed with corneal ulcer, os - progressive and was advised to continue prednisolone acetate 1% ophthalmic suspension, os, four times a day and moxifloxacin 0.5% ophthalmic solution every two hours.On (b)(6) 2015, the consumer visited the ophthalmologist for a follow up visit.The consumer complained of decreased vision and irritation on os since morning.The consumer was still not wearing contact lenses.Slit lamp examination revealed 0.5 x 0.5 mm corneal ulcer os - worsening.She was diagnosed with corneal ulcer, os - progressive contributing to symptoms.It was reported that the consumer went for a long period of time without any drops and was restarted with moxifloxacin 0.5% ophthalmic solution every hour (os) and was given with a sample of besifloxacin ophthalmic suspension 0.6% every hour.On (b)(6) 2015, the consumer visited the ophthalmologist for a follow up visit.The consumer reported cloudy vision on os and she was wearing eyeglasses.Slit lamp examination revealed inferior opacities in the cornea, od and paracentral ulceration 1x1 epithelial defect in the cornea, os.The consumer was diagnosed with central corneal ulcer, os - improved and unspecified corneal opacity, both eyes (ou) - stable old scarring.She was advised to continue moxifloxacin 0.5% ophthalmic solution every hour (os) and prednisolone acetate 1% ophthalmic suspension, os, four times a day.On (b)(6) 2015, the consumer visited the ophthalmologist for a follow up visit.The patient reported that her os was still irritated, red and blurry.She added that her husband has a fungal infection on his toe and she believed that she may have touched her eye afterwards.Slit lamp examination revealed a clear cornea, od and paracentral ulceration 1x1 epithelial defect, corneal haze, scarring in the cornea, os.She was diagnosed with central corneal ulcer, os - advance, unspecified corneal opacity, ou - stable and was advised to continue moxifloxacin 0.5% ophthalmic solution every hour (os) and prednisolone acetate 1% ophthalmic suspension, os, four times a day.She was referred to another ophthalmologist.On (b)(6) 2015, the consumer visited the ophthalmologist for a consult.During the consult, the consumer reported that her husband has a fungal toe infection and she has been helping him clean his foot.She would wash his feet and was afraid that she got fungus in her eye.She added that they had "bad" escherichia coli contamination of their water system three weeks prior.They were on water boiling precaution for all tap water.The ophthalmologist believed it was most likely ak and noted that the consumer has perineuritis at five o'clock.External examination revealed ptosis in os.Slit lamp examination of os revealed mild lid edema, elevated tear lakes, 3+ diffuse injection in the conjunctiva, 6 mm central ring infiltrate with minimal thinning and intact epithelium, hazy view anterior chamber, hazy view of the iris and lens.The consumer was still on moxifloxacin 0.5% ophthalmic solution one drop to eye three times a day and prednisolone acetate 1% ophthalmic suspension one drop four times a day.The consumer was prescribed with propamidine every hour, chlorhexidine every hour, acetaminophen/codeine 20 tablets and atropine sample twice a day.She was diagnosed with corneal ulcer, os - primary, corneal ulcer, unspecified.On (b)(6) 2015, the consumer visited the ophthalmologist for a follow up visit.She reported that she was experiencing throbbing pain in her os which she believed was due to the corneal swabs that she had done.She added that the sensation has been getting worse especially when eye drops were instilled.She reported that the pain was so severe that she became nauseous and the pain kept her awake.The pain was felt at the back of her head to the nasal area including her gums.Slit lamp examination revealed 3+ injection in the conjunctiva, ak, with perineuritis, corneal haze and scarring of the cornea, os.She was diagnosed with central corneal ulcer, os-advanced acanthamoeba present.She was advised to continue with the acanthamoeba specific fortified medications and was started on pain medication atropine twice a day, os.On (b)(6) 2015, the consumer visited the ophthalmologist for a follow up visit for eye pain.It was noted that the infection was responding to the topical medications.She was prescribed with fluorometholone 0.1% ophthalmic suspension one drop into the left eye two times a day and was advised to continue moxifloxacin 0.5% ophthalmic solution one drop to eye, three times a day and prednisolone acetate 1% ophthalmic suspension one drop four times a day.She was diagnosed with corneal ulcer of left eye-primary.On (b)(6) 2015, the consumer visited the ophthalmologist for a follow up visit.The consumer reported that her vision in her od was blurry and she has no vision in her os and she always has headaches on the left side of her head.Slit lamp examination revealed 3+ injection in the conjunctiva, ak with perineuritis, corneal haze, scarring in the cornea, os.She was diagnosed with unspecified corneal ulcer, os - advanced, other age-related incipient cataract, bilateral, ou - early and open angle with borderline findings, high risk, bilateral, ou - high risk iop borderline os.She was advised to continue propamidine and chlorhexidine alternating daily every two hours, and restart brinzolamide/brimonidine tartrate ophthalmic suspension, three times a day, os only which was given in the past but the consumer was not taking.On (b)(6) 2015, the consumer visited the ophthalmologist for a follow up visit.It was reported that there was evidence of toxicity and ak looked less active.The consumer's medications were tapered.Propamidine and chlorhexidine were reduced to four times per day, one medication at a time alternating days.And she was prescribed with loteprednol etabonate 0.5% gel, one drop into the left eye two times a day.She was diagnosed with corneal ulcer, left ¿ primary.On (b)(6) 2016, the consumer visited the ophthalmologist for a follow up visit for blurred vision.A list of her medications include chlorhexidine 0.02% opthalmic solution, one drop every hour which she was not taking, fluorometholone (fml liquifilm) 0.1% ophthalmic suspension, one drop into the os two times a day which she was not taking, fluorometholone (fml ) 0.1% ophthalmic suspension, one drop into the os two times a day which she was taking, loteprednol etabonate 0.5% gel, one drop into the left eye two times a day which she was not taking, moxifloxacin 0.5% ophthalmic solution, one drop to eye three times a day which she was not taking, prednisolone acetate 1% ophthalmic suspension one drop four times a day which she was not taking and propamidine isethionate 0.1% opthalmic solution one drop every hour which she was not taking.It was reported that there was no evidence of infection during the consult.She was diagnosed with corneal scar, os - primary.No further information is available.

• Brand Name: OPTI-FREE EXPRESS MULTI-PURPOSE 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6670649
• MDR Text Key: 78495032
• Report Number: 1610287-2017-00046
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• 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?: No
• Date Manufacturer Received: 08/04/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 22 YR