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

Catalog Number CBV92001889

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

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Endophthalmitis (1835); Intraocular Infection (1933); Loss of Vision (2139); Burning Sensation (2146); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 05/01/2020

Event Type  Injury  

Event Description

A consumer reported experiencing an infection, eye pain, tearing and vision loss after wearing a contact lens in the right eye.The consumer reported history of contact lenses wear for over 20 years and has used different brand.The consumer informed following hand hygiene and disinfectant solution.The consumer sought treatment with medical doctor, and was treated with ¿injections into cornea, eye drops, and antibiotics, further eye drops for pupil dilation, steroids, and anti-inflammatories.¿ additionally, took oral medication to alleviate eye pain.Additional information was requested for this event.Upon follow up the consumer informed of a corneal ulcer / endophthalmitis per laboratory guide that included collection of corneal secretion.The consumer informed having an ultrasound of the eye that showed ¿phakic, diameter 25.7 mm regular macular area, evident papillary excavation, high mobility and low reflectivity membranous echoes suggestive of posterior total vitreous detachment, condensed point echoes of low reflectivity and high mobility suggestive of an inflammatory/hemorrhagic process.¿ eye ointment was prescribed and was registered by a doctor a for a cornea transplant.The consumer¿s condition is ongoing at the time of the report.Additional information has been requested but not yet received at the time of this report.This the first product event for this report.

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).

Manufacturer Narrative

H.3., h.6.: the actual complaint product was not returned for evaluation.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.No complaint or manufacturing trend was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received which states that the consumer experienced corneal scar and wanted a special lens to cover the scar.Additionally, the consumer will have three corneal examinations.The consumer was treated with a combination of dorzolamide and timolol, travoprost, carboxymethylcellulose and dexpanthenol.It was also reported that consumer wore colored lenses from another brand; however, it did not resolve the problem, with additional information; a serious event, cannot be ruled out at this time of report.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The actual complaint product was not returned for evaluation.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.No abnormality of internal periodic trending during this investigation review.No product return for evaluation therefore no root cause identified for this investigation.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX AQUA
• 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: 13548773
• MDR Text Key: 285740418
• Report Number: 3006186389-2022-00003
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/18/2022

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 Expiration Date: 10/31/2022
• Device Catalogue Number: CBV92001889
• Device Lot Number: 10383985
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 03/02/2022; 05/09/2022; 07/04/2022
• Supplement Dates FDA Received: 03/25/2022; 06/06/2022; 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: OPTI-FREE SOLUTION UNSPECIFIED.
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Female