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

Lot Number 10311866

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

An unopened sample from the complaint lot has been received 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)(6).(b)(4).

Event Description

As initially reported by the consumer via telephone, the consumer experienced discomfort just after wearing the contact lens.On (b)(6) 2017, medical attention was sought.The consumer was diagnosed with a suspected ulcer and serratia infection.The consumer was given antibiotic eye drops four to six times a day and anti-inflammation eye drops four to six times a day.The consumer was instructed for a follow up check up a month later.The patient's eye was reported as improving.Further information was received that day, the patient had visited the ecp on three occasions; (b)(6) 2017.The patient was given colistimethate sodium and erythromycin lactobionate ointment; treatment modality and duration was not provided.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Event Description

Further information obtained from a survey form was received on 10/06/2017.Medical attention was sought on (b)(6) 2017 in which an ulcer was confirmed at ten o'clock location of the right eye and the area around it was red.The patient had a follow up visit on (b)(6) 2017 and confirmed recovery of the eye.It was confirmed that aside from the contact lens, eyelash extensions and nail art had also contributed to the event.It was noted that the presumable cause were lens and care usage.

Manufacturer Narrative

Unopened product from the complaint lot 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.The root cause could not be determined.(b)(4).

• 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: 6948632
• MDR Text Key: 89358177
• Report Number: 3006186389-2017-00079
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Lot Number: 10311866
• Other Device ID Number: 000000000010042505-155673400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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