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

Lot Number 10298729

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Abrasion (1789); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation.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.(b)(4).

Event Description

It was reported by a consumer's representative, on 03-28-2017, that a female consumer put on the lenses in question and experienced a blurred stain on the contact lenses after 3-4 days of wearing it.The consumer visited an ophthalmologist and was diagnosed with corneal erosion in the left eye (os); "the ophthalmologist did not mention any causal relationship between the corneal erosion and the contact lenses." the consumer was prescribed with an unspecified treatment for an unspecified duration and is currently wearing glasses.The consumer was scheduled for a control visit with the ophthalmologist after 2 weeks.Additional information has been requested but not yet received.

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.

Manufacturer Narrative

Both the actual complaint product and unopened/unused product from the complaint lot were returned for evaluation; the product evaluated was found to meet manufacturing specifications.No update to the previously reported investigation was warranted.

Event Description

Additional information was received on (b)(6) 2018 via a telephone call.The consumer reported that the symptoms had been resolved in the middle of (b)(6) 2017 which was confirmed by a doctor.

• Brand Name: AIR OPTIX AQUA
• 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: 6515280
• MDR Text Key: 73461119
• Report Number: 3006186389-2017-00025
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Lot Number: 10298729
• Other Device ID Number: 000000000010042414-155673300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• 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): Other; Required Intervention