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

Catalog Number CBVUNK00073

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

Patient Problems Conjunctivitis (1784); Corneal Edema (1791); Erythema (1840); Pain (1994); Visual Impairment (2138); No Code Available (3191)

Event Date 07/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As initially reported by consumer via email on 11aug2020, it was stated that on (b)(6) 2020 patient complained of redness and lacrimation in both eyes.On (b)(6) 2020, upon initial examination by an ophthalmologist, patient was diagnosed with "other form of dermatitis and myopia".Punctate epithelia was performed on the entire surface of the cornea; two superficial infiltrates up to 2mm in diameter was noted in the right eye; medium depth was noted in anterior chamber along with active reaction of the pupil to light.Subsequently, antibacterial topical eye drop and nonsteroidal anti inflammatory drugs were prescribed for 3 days.On (b)(6) 2020, patient complained of low vision, pain and redness and it was confirmed that patient bought lenses without fitting from optics.Viscometer measurement (vis) revealed 0.04 sphere -6.0 = 0.5 and eye examination revealed blepharospasm; pernicorneal conjunctiva injection, corneal infiltrate superficial in the paraopic zone increased to size up to 5 mm in the projection of 3 o'clock, small multiple precipitates on the endothelium and corneal edema in the epithelium was noted.Examination was difficult due to blepharospasm.Patient was diagnosed with keratouveitis due to contact lens wear with high myopia in the right eye.Patient underwent injection and physiotherapy treatment.On (b)(6) 2020, patient was still experiencing low vision (vis od: 0.04 sphere -6.0 = 0.7) with less irritated eye and hyperemic conjunctiva, non-pericorneal injection was insignificant, cornea edema in the epithelium on the right eye was absent, and infiltrate was para-centrally resolved.Improvement was noted in opacities of the cornea of right eye.On (b)(6) 2020, patient complained of low vision in the right eye; less irritated eyes, less conjunctival hyperemia.Symptoms are improving.A separate record has been created for events associated with left eye examination.Additional information has been requested but not yet received; this complaint will be re-assessed upon the receipt of new information.

• Brand Name: AIR OPTIX AQUA
• 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
• Manufacturer (Section G): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 10500107
• MDR Text Key: 205962482
• Report Number: 3006186389-2020-00007
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00073
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/07/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR