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

Catalog Number 000000000010124229

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

Patient Problems Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Excessive Tear Production (2235); Eye Pain (4467); Swelling/ Edema (4577)

Event Date 03/10/2023

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

The consumer reported that after a few hours of wearing the contact lenses, she felt so much discomfort in her left eye that she wanted to remove them.Eye was red and painful.The next day she had swelling, secretion and pain in the eye.The consumer sought emergency care clinic where corneal ulcer was diagnosed.She was medicated and is being followed up for treatment.Upon follow up it was confirmed that reaction occurred in only left eye and antibiotic moxifloxacin, dexpantenol and sodium hyaluronate treatment was provided to the consumer.The current status of consumer¿s eye was not resolved at the time of this report.Additional information has been requested but not yet received.

Manufacturer Narrative

H.3., h.6.: the actual complaint product was returned and was found to meet manufacturing specifications.An update to the manufacturing review has been requested.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 to update any significant changes.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

H3, h6: 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.

• 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: 16654612
• MDR Text Key: 312407709
• Report Number: 3006186389-2023-00001
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 000000000010124229
• Device Lot Number: 10626684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• 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.; AIR OPTIX PLUS HYDRAGLYDE.; MEDICINAL PRODUCT.
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female