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

Catalog Number 000000000010095494

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Blurred Vision (2137); Loss of Vision (2139); Eye Infections (4466); Swelling/ Edema (4577)

Event Date 12/15/2023

Event Type  Injury  

Event Description

As initially reported by consumer experienced terrible itching and blurred vision within two hours of contact lens wear that caused infection and permanent damage to her eye for which she was prescribed with prednisone drops once symptoms were resolved she tried air optix again which leads to same reaction.Medical records were received which include physical examination shows eye abnormality and bilateral upper eyelids appear to be swollen.Pupils equal round and reactive to light bilaterally, normal conjunctiva bilaterally, well developed, well nourished and no apparent distress.The current condition of the consumer eye is resolved at the time of this report.

Manufacturer Narrative

H.3., h.6.: the complaint sample has been 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

Mdr h.6.: fda event code was removed and fda impact code updated.H.3., h.6.: the actual complaint product (unopened) was 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.D.4.: this is the first of two reports for the same patient involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to (b)(4) for the reported lot number 10628465.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by consumer stating that she experienced terrible itching and blurred vision within two hours of contact lens wear which resulted in infection and permanent damage to her eyes.Consumer was prescribed with prednisone eye drops by eye care professional (ecp).Physical examination was also conducted which revealed eyes abnormality and bilateral upper eyelids were swollen, pupils were equal round and reactive to light bilaterally and normal conjunctiva bilaterally.The current status of the consumer eye is resolved at the time of this report.Additional information has been requested but not yet received at the time of the report.

• Brand Name: AIR OPTIX COLORS
• 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: 18934726
• MDR Text Key: 338070881
• Report Number: 3006186389-2024-00012
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 000000000010095494
• Device Lot Number: 10607404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AIR OPTIX COLORS.; AMPHETAMINE/DEXTROAMPHETAMINE 30MG CAP.; BUPROPION HCL 300 MG PO TB24.; DULOXETINE DR 60MG CAP.; LISINOPRIL 20 MG TAB.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female