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

Lot Number 31255302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Ulcer (1796); Pain (1994); Increased Sensitivity (2065); Blurred Vision (2137); Discharge (2225); Corneal Infiltrates (2231)

Event Date 04/15/2017

Event Type  Injury  

Event Description

Additional information was received on 09/12/2017 via fax. Per ae form, patient wore the lenses in two continuous days and the onset of symptoms started. Patient experienced moderate eye redness. The location of the ulcer and infiltrates were peripheral. The best corrected visual acuity (bcva) of the patient after the symptoms resolved was 20/25.

Manufacturer Narrative

Unopened product from the complaint lot 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. Twelve retain samples from the complaint lot were inspected and were found to meet manufacturing specifications for package integrity. 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).

Event Description

It was reported by the patient's husband on (b)(6) 2017 via telephone call that after a couple of days wearing the contact lenses, the patient developed a corneal ulcer. The patient sought medical attention and has discontinued contact lens wear. It was reported that the event had resolved. Additional information was received on 25aug2017 via faxed medical records. It was reported that the patient visited an ophthalmologist on (b)(6) 2017 for corneal ulcer in the right eye (od). History of present illness reported that the patient wore the contact lenses in the od for a couple of days and experienced a sudden onset of extreme sensitivity to light and pain in the od and her vision was blurry. She visited the emergency department on (b)(6)2017 and was prescribed with moxifloxacin eye drops every hour (od) while awake for the corneal ulcer. It was added that she was still sensitive to light but pain and her visual acuity were improved. Anterior segment examination revealed trace diffuse injection in the conjunctiva od, pinpoint epithelial defect at 7 o clock mid periphery with surrounding consolidating infiltrate in the cornea od and 2-3 + nuclear sclerosis of the lens (ou). The patient was diagnosed with corneal ulcer of od -new, corneal disorder due to contact lens, od - new and cataract, nuclear sclerotic, both eyes (ou) - new. She was advised to continue with moxifloxacin eye drops every hour while awake od, was reminded with contact lens hygiene and was scheduled for a follow up visit the next day. On (b)(6) 2017, the consumer visited the ophthalmologist for a follow up visit for the one-day recheck of the corneal ulcer, od. It was reported that the od has improved since the last visit. It was less sensitive to light, with only slight lacrimation and discharge, no pain and vision has improved. Anterior segment examination revealed stable pinpoint epithelial defect at 7 o clock mid periphery, more consolidated surrounding infiltrate in the cornea od and 2-3 + nuclear sclerosis of the lens (ou). The patient was diagnosed with corneal ulcer of od - stable, corneal disorder due to contact lens, od - stable and cataract, nuclear sclerotic, both eyes (ou) - stable. She was advised to decrease moxifloxacin eye drops from every hour to every two hours while awake, od and was scheduled for a follow up visit on the following day. On (b)(6) 2017, the consumer visited the ophthalmologist for a follow up visit for the one-day recheck of the corneal ulcer, od. It was reported that there were no changes since the last visit and the patient continued with the moxifloxacin eye drops every two hours as directed. Anterior segment examination revealed patch of heaped epithelial defect at 7 o clock mid periphery, surrounding consolidating infiltrate, resolved epithelial defect in the cornea od and 2-3 + nuclear sclerosis of the lens (ou). The patient was diagnosed with corneal ulcer of od - stable, corneal disorder due to contact lens, od - stable and cataract, nuclear sclerotic, both eyes (ou) - stable. She was advised to use moxifloxacin eye drops six times a day od and was scheduled for a follow up visit a couple of days after. On (b)(6) 2017, the consumer visited the ophthalmologist for a follow up visit for the recheck of the corneal ulcer, od. It was reported that the patient was doing much better, she was no longer experiencing pain, redness, photophobia, discharge or blurred vision and continued with the moxifloxacin eye drops every two to three hours while awake. Anterior segment examination revealed consolidated opacity at 7 o clock, no epithelial defect, no stromal cell in the cornea od and 2-3 + nuclear sclerosis of the lens (ou). The patient was diagnosed with corneal ulcer of od - improving, corneal disorder due to contact lens, od - improving and cataract, nuclear sclerotic, both eyes (ou) - stable. It was noted that the corneal ulcer was healing well, the epithelial defect was completely healed and the corneal opacity was consolidating. She was advised to use moxifloxacin eye drops every three hours od, she may use artificial tears between moxifloxacin for comfort, she was not allowed to wear contact lenses until the corneal ulcer has completely healed and was advised not to rub her eyes. She was scheduled for a follow up visit three days after. On (b)(6) 2017, the consumer visited the ophthalmologist for a follow up visit for the recheck of the corneal ulcer, od. It was reported that the patient¿s eye was doing good but she was experiencing some scratchy feeling on and off. She was using moxifloxacin eye drops every three hours daily. External eye examination revealed slight swelling, dermatochalasis on the lid, od. Anterior segment examination revealed consolidated opacity at 7 o clock, no epithelial defect, no stromal cell in the cornea od and 2-3 + nuclear sclerosis of the lens (ou). The patient was diagnosed with corneal ulcer of od - improving, corneal disorder due to contact lens, od - improving, cataract, nuclear sclerotic, both eyes (ou) - stable and dermatochalasis - now. It was noted that the corneal ulcer od has improved and there was still opacity but no active infection. She was advised to use moxifloxacin eye drops every four hours od, she was still not allowed to wear contact lenses and was scheduled for a follow up visit three days after. On (b)(6) 2017, the consumer visited the optometrist for a follow up visit for the three-day recheck of the corneal ulcer, od. It was reported that the patient¿s od was better since the last visit but the patient was experiencing some irritation off and on and lacrimation. There was no pain or light sensitivity and there was no change in her vision. She was using moxifloxacin eye drops four times a day. External eye examination revealed 2+ dermatochalasis in the lid, ou. Anterior segment examination revealed inferior temporal stromal scar 1 mm round, no staining, no infiltration, no stromal edema in the cornea od and 2-3 + nuclear sclerosis of the lens (ou). The patient was diagnosed with corneal ulcer of od - improving, corneal disorder due to contact lens, od - stable, cataract, nuclear sclerotic, both eyes (ou) - stable, dermatochalasis of both upper eyelids - stable and presbyopia ou - stable. It was noted that the corneal ulcer od had resolved, there was no staining but stromal scar remained. She was advised to continue the use of moxifloxacin eye drops, four drops daily for four more days od. She was still not allowed to wear contact lenses until her scheduled follow up visit after two to three weeks for blepharoplasty consult. It was added that the patient understood the importance of using topical medications as directed and follow up visits.

• 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: 6835395
• MDR Text Key: 261584080
• Report Number: 9681121-2017-00066
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/31/2021
• Device Lot Number: 31255302
• Other Device ID Number: 000000000010043897-155700001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 08/31/2017 Patient Sequence Number: 1

Treatment

ALPRAZOLAM, 0.5 MG ORAL TABLET; ASPIRIN, 81 MG TABLET; ATENOLOL, 50 MG ORAL TABLET; ATORVASTATIN CALCIUM, 40 MG; BUDESONIDE, 3 MG ORAL CAPSULE; CALCIUM 600-D TABS; CLONAZEPAM, 2 MG ORAL TABLET; DULOXETINER HYDROCHLORIDE, 60 MG; FENOFIBRATE, 54 MG ORAL TABLET; FISH OIL CAPSULE; FLUOXETINE HYDROCHLORIDE, 20 MG; HYDROCODONE ACETAMINOPHEN; LANSOPRAZOLE, 15 MG ORAL CAPSULE; LISINOPRIL, 20 MG ORAL TABLET; METAMUCIL CAPSULE; METFORMIN HYDROCHLORIDE, 500 MG; MIRTAZAPINE 30 MG ORAL TABLET; MOXIFLOXACIN 0.5% OPHTHALMIC SOLUTION; MULTI-VITAMIN TABLET; MUPIROCIN CALCIUM CREAM, 2%; NITROGLYCERIN, 0.4 MG SUBLINGUAL; NYSTATIN, 100000 UNIT/GM; TEMAZEPAM, 30 MG ORAL CAPSULE