MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX FOR ASTIGMATISM; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 31248582

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Irritation (1941); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

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 31248582.The actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.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 initially reported by a female consumer that she experienced irritation on her left eye (os) and her os felt dry after she removed the complaint contact lenses.It was added that her eyes were fine and that the symptoms had resolved.Additional information was received on 11/24/2017 via a telephone call.The consumer reported that she experienced an eye infection and an ulcer.She added that she was not willing to give any further information.No further information can be obtained at this time.

• Brand Name: AIR OPTIX FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer (Section G): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7137193
• MDR Text Key: 95452663
• Report Number: 9681121-2017-00077
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

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: 06/30/2021
• Device Lot Number: 31248582
• Other Device ID Number: 000000000010035920-155670800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/12/2018
• Supplement Dates FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other