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

Lot Number 10282486

Device Problem Microbial Contamination of Device (2303)

Patient Problem Fungus (1872)

Event Date 07/18/2017

Event Type  Injury  

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.The root cause could not be determined.(b)(4).

Event Description

It was reported via website on 07/31/2017 by a female consumer that the contact lenses for the right eye (od) presented with a fungus in less than two days.She went to an ophthalmologist with ¿bacteria in her eyes¿ and the lens was found to be ¿bad¿.Additional information received on 08/01/2017 reported that the fungus caused unspecified harm on the consumer¿s eye and the ophthalmologist confirmed that there were bacteria and fungus.The consumer was prescribed with unspecified antibiotics for seven days and an unspecified eye drop with unspecified duration.It was reported that the event had 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
• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6826924
• MDR Text Key: 83869013
• Report Number: 3006186389-2017-00076
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K133176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Lot Number: 10282486
• Other Device ID Number: 000000000010095322-155673380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR