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

Catalog Number CBVUNK00007

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

Patient Problems Corneal Abrasion (1789); Intraocular Infection (1933); Visual Impairment (2138)

Event Type  Injury  

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).

Event Description

As initially reported by a female consumer via email on (b)(6) 2021 and the follow up information received on 06aug2021.It was stated that on an unknown date, the consumer experienced severe corneal infection with these lenses.On (b)(6) 2021, the consumer sought medical attention and was diagnosed with cornea scratch.On an unspecified date, the culture test was performed and the result showed bacterial infection.It was also stated that the infection caused decrease in visual acuity by 2 snellen lines.The consumer was prescribed with drops and lubricants as s treatment.Symptom resolution was unknown.Additional information has been requested but not yet received.

Manufacturer Narrative

B5., d9., h3.; new information has been received and the additional information has been updated.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received on 24-sep-2021.The symptoms were resolved.

• 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
• MDR Report Key: 12372412
• MDR Text Key: 268298751
• Report Number: 3006186389-2021-00007
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K133176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00007
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability