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

Catalog Number CBV92027782

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Hypersensitivity/Allergic reaction (1907); Pain (1994); Red Eye(s) (2038); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The manufacturer internal reference number is: (b)(4).

Event Description

It was initially reported on (b)(6) 2018 that the consumer experienced red eyes after removal of the contact lenses 14 hours after use.It was reported that the consumer experienced swollen eyes, eye pain and light sensitivity the following morning.It was reported that the consumer had three corneal ulcers on the right eye (od) with diffuse infiltrates and two corneal ulcers on the left eye (os) with diffuse infiltrates.The consumer was on moxifloxacin antibiotics every hour and was reported to be responding well to the treatment.Additional information was received on 09apr2018 and it was reported that the corneal ulcers on both eyes (ou) were located superior 2-3mm.The treatment with moxifloxacin antibiotic has now been decreased to four times a day.It was also reported that the consumer has permanent scarring on both eyes.Additional information has been requested but not yet received.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.A trend related investigation was performed; no trend could be identified.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.

• Brand Name: AIR OPTIX COLORS
• 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: 7478768
• MDR Text Key: 107076854
• Report Number: 3006186389-2018-00015
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K133176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: CBV92027782
• Device Lot Number: 10365346
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR