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

Catalog Number 000000000010125237

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

Patient Problems Inflammation (1932); Keratitis (1944); Red Eye(s) (2038); Blurred Vision (2137); Eye Pain (4467)

Event Date 11/13/2023

Event Type  Injury  

Event Description

Initially reported by a health professional, the consumer experienced blurry vision, eye pain, and red eyes.Follow up information was received from the consumer stating redness on both eyes after wore this trial contact lens for 1 day and visited an ophthalmologist on 14/nov/2023, the physician suspected serious eye inflammation and the consumer was diagnosed with keratitis - infectious.Eye drops were prescribed.At the time of the report symptoms are improving.Additional info has been requested and received on 27-nov-2023 stated ophthalmologist prescribed fluorometholone 0.1% and moxifloxacin hydrochloride ophthalmic solution 0.5% for 1 week period usage to the consumer.The consumer don¿t have any redness of eye and pain currently.

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).

Manufacturer Narrative

H.3., h.6.: an open two lenses was received for evaluation in flat pack container without labelling.An additional evaluation report was filed to identify complaint product.Based on the evaluation result filed under manufacturer internal reference number of (b)(4).It is found that sample one product was found to be consistent and related to the current file i.E., manufacturer internal reference number: (b)(4).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 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: 18220373
• MDR Text Key: 329157024
• Report Number: 3006186389-2023-00022
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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,Followup
• Report Date: 01/04/2024

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: 000000000010125237
• Device Lot Number: 10601556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM.
• Patient Outcome(s): Other