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

Lot Number 10315084

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Irritation (1941); Pain (1994); Red Eye(s) (2038); Discomfort (2330)

Event Date 04/01/2017

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.Another report will be filed under (b)(4)for a description of the other lot reported lot number.Unopened product from this complaint lot has been 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

As initially reported by an eye care professional, a patient experienced discomfort and foreign body sensation associated with the wearing of a contact lens for which a surface defect was seen.Further information received via completed adverse event questionnaire stated that patient experienced "grain of sand" sensation, irritation, and pain in her right eye immediately upon wearing of the contact lens; severe eye redness was also reported.The patient was diagnosed with a corneal ulcer.

Manufacturer Narrative

The unopened product 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.(b)(4).

Event Description

Initial report: as initially reported by an eye care professional, a patient experienced discomfort and foreign body sensation associated with the wearing of a contact lens for which a surface defect was seen.Further information received via completed adverse event questionnaire stated that patient experienced "grain of sand" sensation, irritation, and pain in her right eye immediately upon wearing of the contact lens; severe eye redness was also reported.The patient was diagnosed with a corneal ulcer.Correction: initially, it was reported that the event resolved with no sequela and that the patient has resumed contact lens wear.

• 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: 6847398
• MDR Text Key: 85090466
• Report Number: 3006186389-2017-00078
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• 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: 10315084
• Other Device ID Number: 000000000010042525-155673400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR