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

Lot Number 10274470

Device Problem Material Deformation (2976)

Patient Problem Corneal Ulcer (1796)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

This is the first of two reports for the same patient, as product was received for evaluation from both complaint lot number 10274470 and an unknown complaint lot.This report represents complaint lot 10274470; please see additional report submitted under manufacturer internal reference number (b)(4) for a description of the unknown complaint lot received.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

As reported by an optician on (b)(6) 2016, a consumer experienced a corneal ulcer due to deformed contact lenses.The event was reported as resolved.Additional information has been requested, but has not been received.

Manufacturer Narrative

This is the first of two reports for the same patient, as product was received for evaluation from both complaint lot number 10274470 and an unknown complaint lot.This report represents complaint lot 10274470; please see additional report submitted under manufacturer internal reference number (b)(4) for a description of the unknown complaint lot received.Only packaging was returned for evaluation 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.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).

• Brand Name: AIR OPTIX AQUA MULTIFOCAL
• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6284902
• MDR Text Key: 66006203
• Report Number: 3006186389-2017-00007
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Lot Number: 10274470
• Other Device ID Number: 000000000010073879-155700172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• 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