MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX PLUS HYDRAGLYDE; EXTENDED WEAR SOFT CONTACT LENS

Catalog Number CBVUNK00148

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

Patient Problems Corneal Abrasion (1789); Corneal Edema (1791); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Corneal Infiltrates (2231); Eye Infections (4466)

Event Date 09/30/2023

Event Type  Injury  

Event Description

As initially reported by other health care professional states that, consumer is experiencing burning, stinging and had a very allergic reaction to the lenses.Consumer discontinued wearing them and then had another irritant reaction +++.Consumer sought ophthalmological emergency room.Additional information received which states that consumer had a follow-up visit optician stated event starts on (b)(6) 2023 and that both eyes impacted as left and right lenses.The consumer used other brand lens care solution.Additionally, the consumer went to a&e following swelling during the night and was diagnosed with corneal edema along with an infection to the left eye.The consumer was treated with ofloxacine with the dose of one drop, six times a day, dexamethasone and oxytetracycline one application in the evening for five days.Consumer had an office visit with an ophthalmologist, who prescribed carbomer and a vitamin a ointment to be applied every evening for a month.Consumer returned to office visit with an infection and "micro breaches" as per voice of consumer for both eyes of the cornea and was treated with vitamin a ointment one application a day in the evening for seven days, carbomer one drop four times a day for fifteen days and cethexonium bromide one drop three times a day for seven days.During a follow-up check-up, the infection had healed, but there were infiltrates in the left eye in addition to micro breaches and was treated for both eyes with vitamin a ointment and carbomer one drop four times a day, reinforced treatment in the left eye with combination of tobramycine and dexamethasone one drop, five times a day for five days, then one drop, four times a day for five days etc., hexamidine di-isethionate one drop twice a day.Consumer had additional visit states right eye healed but micro-breaches and infiltrates still present in the left eye.Tobradex treatment to be continued until progressive end and ointment every evening.Last treatment with sodium hyaluronate solution.The current status of consumer¿s eye was continuing at the time of this report.Additional info has been requested but not yet received.

Manufacturer Narrative

H.3., h.6.: 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).

• Brand Name: AIR OPTIX PLUS HYDRAGLYDE
• Type of Device: EXTENDED WEAR SOFT CONTACT LENS
• 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 ; 8007579780
• MDR Report Key: 18158573
• MDR Text Key: 328361006
• Report Number: 3006186389-2023-00020
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00148
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DIA LENS CARE SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Sex: Female