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

Catalog Number 000000000010124517

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

Patient Problems Conjunctivitis (1784); Acanthameba Keratitis (1945); Red Eye(s) (2038); Burning Sensation (2146); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 04/10/2023

Event Type  Injury  

Manufacturer Narrative

H.3., h.6.: the actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.A trend related investigation was performed; no trend could be identified.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).

Event Description

A health care professional reported on behalf of a consumer who experienced burning, eye pain, tearing, red eyes and was diagnosed with keratitis.Additional information was received which states that the consumer attended the consultation with conjunctival hyperemia.The ophthalmologist told the consumer to change his contact lenses as they damaged his eyes and it later turned to conjunctivitis.Follow-up information was received, which states that the consumer experienced bacterial infectious keratitis and was treated with tobramycin and dexamethasone ophthalmic drops.The current status of the consumer's eyes is resolved.Further information cannot be obtained.

• Brand Name: AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM
• 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: 17017337
• MDR Text Key: 316116740
• Report Number: 3006186389-2023-00012
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 000000000010124517
• Device Lot Number: 10619406
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AIR OPTIX PLUS HYDRAGLYDE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female