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

Catalog Number CBVUNK00008

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

Patient Problems Corneal Ulcer (1796); Red Eye(s) (2038); Blurred Vision (2137); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 11/09/2023

Event Type  Injury  

Event Description

As initially reported by non-healthcare professional states that the consumer experienced red eyes, eye pain, tearing in eyes, and got dark spots on eye which is affecting vision.Consumer visited the doctor, and an unspecified laboratory test was performed and confirmed green spots on the eyes and it might be keratitis of ulcer, no further additional information regarding the product is known at this time, the current status of consumer¿s eye is unknown.Additional information has been requested but not yet received at the time of report.

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.This is the first of two reports for the same patient involving two different lot numbers of the different product.It is unknown which contributed to the event.Refer to the second report filed under the manufacturer internal reference number of (b)(4).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
• 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: 19009252
• MDR Text Key: 338981691
• Report Number: 3006186389-2024-00020
• 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: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00008
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2023
• 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: AOSEPT PLUS/CLEAR CARE
• Patient Outcome(s): Other
• Patient Sex: Male