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

Catalog Number CBV92001889

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Ulcer (1796); Pain (1994); Red Eye(s) (2038); Burning Sensation (2146); Discomfort (2330)

Event Date 03/27/2018

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

As initially reported by an eye care provider (ecp) via telephone on 28mar2018, a female patient complained of red eye and corneal ulceration.The patient did not wear contact lenses for several weeks.Additional information was received on 16apr2018 from ecp via questionnaire that a (b)(6) female patient experienced physical discomfort and burns with moderate redness and severe pain in the right eye (od) on (b)(6) 2018 immediately upon first use of the lens.The patient had worn contact lenses since 1993 and her habits regarding manipulation and hygiene were correct.Medical attention was sought and found that the patient presented a corneal ulcer.The patient stopped wearing her lenses temporarily and was given unspecified medications, treatment modality and duration were not provided.The event was not resolved but was reported as improving.The patient planned to wear lenses.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from the ecp on (b)(4) 2018 via phone that the patient bought a box of contact lenses on (b)(6) 2018.The ecp thought that since the patient bought new contact lenses, she must had been wearing them without problem.No additional information is available at this time.

Manufacturer Narrative

The complaint 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.A retained sample was tested and was found to meet manufacturing specifications.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
• 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
• MDR Report Key: 7455405
• MDR Text Key: 106330222
• Report Number: 3006186389-2018-00014
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: CBV92001889
• Device Lot Number: 10364881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR