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

Catalog Number 00650363AM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Conjunctivitis (1784); Corneal Ulcer (1796); Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Irritation (1941); Itching Sensation (1943); Keratitis (1944); Blurred Vision (2137); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

As initially reported by the patient's husband via telephone, the complaint product caused discomfort, irritation and dry eye.It was added that the patient was diagnosed with corneal ulcer in her left eye (os) from using the complaint product.Additional information was received on (b)(6) 2017 via faxed medical records.History of present illness reported that the os had a sudden onset of continued ocular inflammation on the entire white of the eye (conjunctiva).The patient experienced discomfort, blurred vision, foreign body sensation and mild itching.The patient had discontinued wearing contact lenses.It was noted that the patient cleaned her contact lenses with the complaint product on (b)(6) 2017 and felt increasingly ¿foggy¿ vision and irritation on the eye after wearing the contact lenses on (b)(6) 2017.On (b)(6) 2017, the patient wore eyeglasses as she felt significant pain in the morning and experienced irritation with eye redness; on the left side more than the right, upon arriving to work.The patient was taken to an urgent care facility where fluorescein dye was used and she was diagnosed with corneal ulcer.She was prescribed with moxifloxacin eye drops.The patient was seen on (b)(6) 2017 for a follow-up visit and reported that her eye felt much better.Slit-lamp examination noted areas of punctate epithelial keratitis bilaterally, more on the os than the od.The patient was diagnosed with superficial punctate keratitis (spk) on the os and mild spk on the od with no signs of bacterial infection.She was advised to continue with moxifloxacin eye drops for two more days and use preservative free lubricating eye drops four times a day.The patient was instructed to consult again if the symptoms persisted and was given discussion regarding single use contact lens and directions for use.Additional information was received from the consumer on 08/31/2017 via telephone that her symptoms had improved but she was not permitted to return to work.Additional information was received from the patient on 09/06/2017 that the she was cleared to return to work on (b)(6) 2017 because the symptoms were resolved.Additional information was received via faxed medical records on 09/08/2017.It was noted that the patient presented to the urgent care facility with burning left eye and was not able to drive due to watery eye on (b)(6) 2017.The patient reported that she used a pair of contact lens that was soaked for a week prior to the event.The patient stated that she experienced photosensitivity and had tetanus immunization up to date.The patient tried water for treatment but it did not alleviate the symptom.It was confirmed through slit lamp examination that the left eye showed corneal ulcer and fluorescein uptake with conjunctival injection.Wood lamp examination showed that the eye was positive with fluorescein staining uptake and a five millimeter corneal ulceration was noted over the lower central aspect of the left cornea.The patient was prescribed with moxifloxacin 0.5% ophthalmic solution one drop to be applied three times a day for seven days and acetaminophen-codeine 300-30 mg per tablet one tablet to be taken per orem every six hours as needed for pain.The patient was educated about the nature of her eye condition, was given home care instructions and was advised for a follow up visit if condition worsens.

Manufacturer Narrative

The complaint product was returned for evaluation and was found to meet manufacturing specifications.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6896889
• MDR Text Key: 87464284
• Report Number: 1610287-2017-00062
• 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: Patient Family Member or Friend
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 00650363AM
• Device Lot Number: 281618F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: IBUPROFEN; LAMOTRIGINE; PROPANOLOL; SUMATRIPTAN; TETANUS IMMUNIZATION; UNKNOWN BIRTH CONTROL MEDICATION
• Patient Outcome(s): Other
• Patient Age: 28 YR