MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA MULTIFOCAL; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92003420

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 08/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The manufacturer internal reference number is: (b)(4).

Event Description

It was reported that on (b)(6) 2015, the consumer renewed her contact lens prescription from her optometrist and used it to purchase a set of alcon¿s air optix mutifocal aqua contact lenses online.On (b)(6) 2015 the consumer purchased four boxes, two boxes for each eye.When the contact lens arrived, the consumer opened one box for each eye and inserted the proper lenses into each eye.The consumer was so bothered by these lenses that she was forced to dispose of them after only a few hours.She used a second set of lenses from the same boxes which still caused persistent irritation to her eyes.On thursday, (b)(6) 2015, the consumer used a third set of contact lenses from the same box.After only a few hours, the consumer was forced to remove the contact lenses due to irritation.The consumer removed the third set of contact lenses and put them in a contact lens solution to clean them.She did not reinsert either these lenses or another set of lenses at any point thereafter.The next day, on (b)(6) 2015, the consumer¿s left eye (os) was irritated and pink.By (b)(6) 2015, the consumer was unable to see out of her os, forcing her to go to an urgent care facility.Two eye care practitioners (ecps) noted the patient has had moderately decreased vision in the os associated with pain, severe photophobia and discharge.It has been associated with redness, discharge, matting and foreign body sensation.The exam of the os revealed mild eyelid edema, moderate conjunctival edema, moderately injected conjunctiva, copious exudate was present, other corneal abnormality (there is a concaved circular lesion that is seen without fluorescein), pupil constricted and non-reactive to light directly and consensually.At this point, the ecp recommended that the consumer go immediately to a tertiary center for eye injuries.Upon arrival to a tertiary center for eye injuries, a third ecp, examined the consumer and during the exam of the os, it was noted that a contact lens was stuck on the eye.There were multiple corneal infiltrate with varying small degrees of overlying epithelial loss and haze.The consumer was diagnosed with a contact lens related corneal ulcer with multiple foci of infiltrate.Contact lens was removed in the clinic.The consumer was given unspecified steroids and antibiotics.Upon return to the hospital the next day, a fourth ecp noted multiple discrete circular corneal infiltrates with varying small degrees of overlying epithelial loss, diffuse haze and mce, +ked 8mm (v) x 4 mm (h).The consumer returned to the hospital on (b)(6) 2015.A fifth ecp noted persistent satellite lesions.On (b)(6) 2015 the diagnosis given by a sixth ecp was contact lens related keratitis left eye (os) unusual presentation with multiple changes following use of new contact lens - appears predominantly inflammatory, probably had two contact lenses on at one point prior to presentation.The consumer was prescribed with prednisone drops to alleviate the pain, reduce the keratitis, swelling and facilitate the healing of the corneal ulcer.The consumer was also prescribed with artificial tears to treat dryness and irritation.On (b)(6) 2015, the third ecp noted that the consumer developed punctate stains, an indication of corneal damage.The impression was ¿contact lens related keratitis os-unusual presentation suspicious for atypical corneal ulcer¿.Started on prednisone last visit with subjective and visual acuity improvement.On (b)(6) 2015, the cultures that had been done to check for growth came back negative.On (b)(6) 2015, a seventh ecp observed a new ¿ked inferonasally without associated infiltrate¿.On (b)(6) 2015, although there was slight improvement, a fifth ecp noted an ¿atypical presentation with multifocal epithelial defects and stromal opacification that may have been related to corneal hypoxia from double contact lens use¿.Prednisone use has there been tapered as the steroid had been causing an increase in the consumer¿s eye pressure.The consumer¿s vision at this point was blurry.She could see in color but it was difficult.On (b)(6) 2015, an eighth ecp noted that the consumer was with pain that is not relieved with propacaine and trace cell in setting of rapid steroid taper.Also with aggressive artificial tears.The consumer was then put back on the steroids due to the onset of symptoms and because the inflammation of the left eye was not improving.On (b)(6) 2015, consumer had continued care where the ecp noted ¿potential scarring¿.On (b)(6) 2016, the consumer returned to the hospital for her 6 month follow up appointment.She continued to have vision issues although the scar on her cornea had diminished.Her eyes frequently itched, requiring the near constant use of eye drops during the day and at night before going to sleep.On (b)(6) 2016 the third ecp informed the consumer that she was not a candidate for laser eye surgery due to the scar at the center of her left eye which came about as a direct result of the contact lens defect.The third ecp¿s prognosis of the consumer is that the damage to the left eye is permanent and that any attempt at corrective surgery would aggravate her ocular issues.Additional information was received on 21may208 via provision of medical records.According to the medical records provided, the consume r was diagnosed with os pain, probable uveitis and possible iritis of the os on (b)(6) 2015.Cultures were taken and the consumer was prescribed with flouromethalone 0.1% ophthalmic suspension one drop into the left eye once daily, lisinopril 20mg tab once daily, butalbital-asa-caff-codeine, and meloxicam 7.5 mg as needed for pain.Slit lamp exam shows a 2-3+ injection on the left conjunctiva, contact lens was present on the left eye with multiple corneal infiltrate with varying small degrees of overlying epithelial loss and haze.The consumer was then started on tobramycin 14mg/ml solution and vancomycin 50 mg/ml every hour while awake.On (b)(6) 2015, the consumer revisited the eye care institute for the corneal ulcer and it was noted that the condition was improving.The consumer was then started on cyclopentolate three times a day on the os and consumer was advised to refrain from using contact lenses.The consumer then returned for follow up on (b)(6) 2015.Vancomycin 50mg/ml was decreased to 25mg/ml to be administered as one drop very hour for three days and tobramycin 14mg/ml was changed to 1 drop into both eyes every hour for 3 days.On (b)(6) 2015 another follow up was made.Slit lamp exam showed reactive ptosis, 3+ injection was noted on the conjunctiva, central anterior stromal haze (mostly wbcs) with multifocal subepithelial opacities (mostly inferior) was noted and 1= cell was also noted in the anterior chamber.The flourometholone 0.1% ophthalmic suspension was discontinued and prednisolone acetate 1% ophthalmic suspension was then started one drop into the os four times a day for 30 days.Another follow up was made on (b)(6) 2015.Slit lamp exam revealed reactive ptosis on the left eye, 1+injection on the left conjunctiva, central anterior stomal haze (mostly wbcs) with multifocal subepithelial opacities, mostly inferiorly, haze and punctate stain was noted on the cornea.Cylopentolate 1% ophthalmic solution was placed on hold.Vancomycin and tobramycin was decreased to every 4 hours.Consumer was advised to use preservative free artificial tears as needed.On (b)(6) 2015, upon slit lamp exam, reactive ptosis was noted and the cornea had central anterior stomal haze with multifocal subepithelial opacities mostly inferior with haze and punctate stain.It was noted that the corneal cultures had no growth.Tobramycin was decreased to three times a day in the left eye and vancomycin was discontinued.The consumer was also started on prednisolone acetate one drop in the os four times a day.On (b)(6) 2015, the slit lamp exam revealed central superficial haze with consolidated focal opacities inferiorly, curvilear ked inferonasally.Vancomycin 50mg/ml and tobramycin 14mg/ml were completed and discontinued.The consumer was then started on trimethoprim-polymyxin b ophthalmic solution one drop into the left eye every six hours.On (b)(6) 2015, the slit lamp exam shown central corneal haze with inferior stromal scarring.On (b)(6) 2015, the slit lamp exam revealed slight corneal haze/central scarring, stomal scarring inferiorly with no epithelial defects.Prednisolone acetate 1% ophthalmic suspension was changed into 1 drop for the left eye four times a day for 30 days.On (b)(6) 2015, the slit lamp exam revealed a slight corneal haze/ central scarring stromal scarring inferiorly with no ked.Prednisone was increased to four times a day for a week to be lowered to three times a day for the following week.Preservative free artificial tears was increased to six to eight times per day.On (b)(6) 2015, upon follow up, it was noted that the central haze continued with potential scarring but with no epithelial defect.Slit lamp exam revealed rare to trace cells present within the anterior chamber indicating uveitis.No additional information is available as of the moment.

Manufacturer Narrative

This is the first of two reports for the same patient involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to (b)(4) for the reported lot number 10227074.The actual complaint product was not returned for evaluation.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.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX AQUA MULTIFOCAL
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• MDR Report Key: 7552121
• MDR Text Key: 109497797
• Report Number: 3006186389-2018-00017
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: CBV92003420
• Device Lot Number: 10220721
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 77