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

Lot Number 10173390

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Abrasion (1789); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Discomfort (2330)

Event Date 04/09/2015

Event Type  Injury  

Manufacturer Narrative

Unopened samples from the known lot was received.The evaluation determined that the samples met manufacturing specifications.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by an optician on (b)(6) 2015, a patient sought medical attention and was diagnosed with a scratch on cornea (corneal abrasion) in the right eye (od); the patient also reported to have experienced foreign body sensation and discomfort with the lenses.No information regarding resolution was provided.Additional information was received from the consumer via letter and the optician via questionnaire on (b)(6) 2015.The optician reported that the patient was diagnosed with a deep scratch on the cornea and a corneal ulcer by an ophthalmologist.The patient reported that she visited the ophthalmologist on (b)(6) 2015 was diagnosed with a deep scratch on the cornea and was prescribed an unspecified eye drop and an unspecified anti-inflammatory ointment.The patient was instructed to discontinue lens wear for one month.Follow up appointment was scheduled for (b)(6) 2015.During the follow up appointment on (b)(6) 2015, the ophthalmologist confirmed that the eye was healed and lens wear may resume.The patient resumed lens wear with lenses from the same box from the initial event.After removing the lens in the evening, the patient reported to experience foreign body sensation and discomfort that lasted the entire night.The patient had an appointment scheduled for (b)(6) 2015 with an eye care professional (ecp) and the patient decided to discontinue lens wear until scheduled appointment.During the appointment on (b)(6) 2015, the ecp diagnosed the patient with a new scratch on eye (od).The patient was prescribed two unspecified eye drops and was instructed to discontinue lens wear for one month.The ecp and the patient suggested that the box of lenses used during the event "could present a manufacturing default".The patient resumed lens wear without issue with lenses from a different box of lenses.The event has resolved.

Manufacturer Narrative

Unopened product from the same lot was returned and found to be within specification.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.A trend related investigation was performed; no trend could be identified.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.

• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5099048
• MDR Text Key: 26597093
• Report Number: 3006186389-2015-00536
• 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
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Lot Number: 10173390
• Other Device ID Number: 000000000010042550-155673400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2013
• 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; Required Intervention
• Patient Age: 44 YR