MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 31218132

Device Problem Insufficient Information (3190)

Patient Problems Corneal Ulcer (1796); Irritation (1941); Itching Sensation (1943); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Increased Sensitivity (2065)

Event Date 08/12/2017

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.A trend related investigation was performed; no trend could be identified.The device history record and sterilization 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.(b)(4).

Event Description

It was reported by a female patient that she experienced itchy eyes, redness, irritation and ulcers on her left eye (os) from wearing the complaint contact lenses.It was added that the symptoms were resolving and the eye drops were reduced to four times a day.The patient mentioned that "the ulcer was so bad that a mesh was put on her eye and a band aid on top of that".Additional information was received on 10/24/2017 via faxed medical records.It was reported that the patient visited an optometrist on (b)(6) 2017 due to a red os.While wearing contact lenses a day prior, her os started to bother her so she removed the contact lenses.She used a new pair of contact lenses and her os started to be really itchy.She removed the contact lenses but the itchiness got worse.The os was throbbing with sharp shooting pains, was watery and was sensitive to light.Slit-lamp observations include a large central corneal ulcer os with haze surrounding it, 2+ bulbar conjunctiva injection os.The patient was diagnosed with central corneal ulcer, os.She was prescribed with ketorolac 0.5%, one drop into the affected eye four times a day as needed for pain, tobramycin/dexamethasone 0.3-0.1% and 1 drop into affected eye four times a day for seven days.While in the doctor¿s office, she was also given one drop of homatropine (os), 1 drop of proparacaine (os), a 12 millimetre (mm) amniotic membrane was inserted on the ocular surface (os) and a bandage contact lens was placed over it.She was prescribed with moxifloxacin (os) every hour for one day and every two hours for the next two days.She was also scheduled for a follow up visit three days after.On (b)(6) 2017, the patient visited the optometrist for a progress check on the corneal ulcer (os).The patient reported that she felt a lot better and that she thought that a part of the amniotic membrane came off but the contact lens was still in place.She added that pain and light sensitivity was much better and the pain medications helped a lot.Slit-lamp observations include a much better central corneal ulcer with haze surrounding it and 1+ bulbar conjunctiva injection (os).The bandage contact lens was removed and the patient was instructed to continue with moxifloxacin six times a day for two days, then four times a day (os).She was diagnosed with central corneal ulcer, os and was also scheduled for a follow up visit three days after.On (b)(6) 2017, the patient visited the optometrist for a progress check on the corneal ulcer (os).The patient reported that the os was feeling much better.Slit-lamp observations include a small central corneal ulcer os ¿ no sodium fluorescein (nafl) staining present.She was prescribed with ketorolac 0.5%, 1 drop into affected eye four times a day as needed for pain, tobramycin/dexamethasone 0.3-0.1%, 1 drop into affected eye four times a day for seven days, moxifloxacin 0.5%, 1 drop into the left eye.For the treatment of the cornea, she was prescribed with tobramycin/dexamethasone four times a day for one week (os).She was diagnosed with central corneal ulcer, os.Additional information was received on 10/27/2017 via a telephone call.It was reported that all of the symptoms have resolved.Additional information was received on 11/09/2017 via faxed medical records.On (b)(6) 2017, the patient reportedly put on a new pair of non-alcon contact lenses and slept in them.On (b)(6) 2017, the patient experienced red eye which was throbbing and tearing.On (b)(6) 2017, the patient¿s eye had secretions and felt scratchy upon waking up.It was reported that the patient visited an optometrist on (b)(6) 2017 due to red os.Slit-lamp observations include corneal infiltrates superior temporal limbus os, 2+ bulbar conjunctiva injection os.The diagnostic impression was infiltrative keratitis superior temporal, os.The patient was prescribed with tobramycin/dexamethasone 0.3-0.1%, one drop into affected eye four times a day for seven days.She was advised to throw away the current contact lenses and discontinue contact lens wear and was scheduled for a follow up visit after four days.She was diagnosed with marginal corneal ulcer, os.On (b)(6) 2017, the patient visited the optometrist for a recheck on the red os.The patient reported that the eye was feeling much better.Slit ¿lamp observations include an almost resolved corneal infiltrates superior temporal limbus os and tr-1+ bulbar conjunctiva injection os.The diagnostic impression was almost resolved infiltrative keratitis superior temporal, os.The patient was advised to continue tobramycin/dexamethasone 0.3-0.1%, one drop into affected eye four times a day for three days and start with new contact lenses.She was diagnosed with marginal corneal ulcer, os.Additional information was received on 11/10/2017 via a telephone call.It was verified by the physician and the patient that the patient had never worn any other contact lens beside the alcon contact lenses and that there was a mistake on the medical records received on 11/09/2017.

Manufacturer Narrative

The complaint product was returned for evaluation 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.

• Brand Name: AIR OPTIX NIGHT & DAY AQUA
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer (Section G): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7032078
• MDR Text Key: 92038631
• Report Number: 9681121-2017-00072
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073459
• 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: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Lot Number: 31218132
• Other Device ID Number: 000000000010043925-155700001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• 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): Other
• Patient Age: 39 YR