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

Catalog Number CBV92000509

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

Patient Problems Irritation (1941); Red Eye(s) (2038); Ulcer (2274)

Event Date 03/04/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided and the complaint sample was not made available for evaluation.Manufacturing site inspected the retain samples of lot: 31350569 to ensure no possibility of product contamination.The retain samples inspection was performed by visual inspection for package integrity and vacuum testing to ensure no leakage or package integrity defect that could lead to contaminate product.The retain samples showed to meet specifications, no leakage and package integrity defect found.Based on the investigation, this lot has passed through all manufacturing process as required by the procedures.The lot was confirmed to meet all in-process and finished product specifications at the time of release.No root cause can be determined.The manufacturer internal reference number is: (b)(4).

Event Description

It was reported on (b)(6) 2019, that the consumer experienced irritation upon use of the complaint contact lens which prompted the consumer to seek the assistance of an eye care professional.On the same day, the consumer was examined by an ecp (examination done was not specified) and the results indicated that there was a small micro-ulcer noted at a 12 o¿clock position.The diagnosis given by the ecp was ¿be (both eyes) contact lens associated red eyes¿.No medication was prescribed for the right eye.Consumer was advised to avoid contact lens wear for the next seven days and to return for follow up in seven days as well.Additional information has been requested but not yet received.

• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8447262
• MDR Text Key: 139669202
• Report Number: 9681121-2019-00005
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: CBV92000509
• Device Lot Number: 31350569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 0
• Patient Outcome(s): Other
• Patient Age: 42 YR