MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 31132431

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

Manufacturer Narrative

This is the second 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 the additional report submitted under manufacturer internal reference (b)(4).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

As initially reported by an optician, a consumer developed a corneal ulcer associated with contact lens wear.The consumer, having worn the same product for many years, reported that the contact lens felt different in comparison to previous ones worn.Additional information has been requested but not yet received.

Manufacturer Narrative

An unknown sample was returned for evaluation and was consistent with the reported lot 31132431.This sample was found to meet manufacturing specifications.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.

Event Description

Additional information was received on 10/14/2017 stating that the consumer has tried another lens after the incident and the corneal ulcer reoccurred.The optician thought that the problem may be with the consumer's eye and not with the lens.Additional information has been requested but not yet received.

• Brand Name: AIR OPTIX NIGHT & DAY AQUA
• 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: 6770545
• MDR Text Key: 81939334
• Report Number: 9681121-2017-00061
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Lot Number: 31132431
• Other Device ID Number: 000000000010043884-155700001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other