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

Catalog Number CBV92003420

Device Problem Product Quality Problem (1506)

Patient Problems Purulent Discharge (1812); Hypopyon (1913); Unspecified Infection (1930); Irritation (1941); Keratitis (1944); Loss of Vision (2139)

Event Date 12/28/2019

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

Event Description

As initially reported by a female consumer via email on 29jan2021.Consumer stated that on (b)(6) 2019, she was no longer wearing contacts because she went blind because of the infection from the contacts.It was also reported that contacts had a lethal parasite and scratched her eye.She was diagnosed with pseudomonas and need a cornea transplant because of going blind in her right eye.Additional information was received on 03feb2021, from her daughter states that incident occurred on (b)(6) 2019, involved od only, additionally patient reports that she put in a new contact lens and immediately felt like there was something in her eye.She tried cleaning the lens and flushing her eye out but this did not help.By the end of the day she had to take the lens out and ended up throwing it away other lenses from the same box were also irritating, it was alsor reported that on saturday of that week she couldn't tell if it was daytime or nighttime as she couldn't see any light.She is already non-seeing in os.After a few days a large pus pocket over the pupil was observed and the patient was referred to cornea specialist.On an unspecified date injections and multiple cultures tests were performed which showed microbial keratitis secondary to pseudomonas aeruginosa and an associated hypopyon.The consumer was treated with combination of antibiotic, antifungal and steroidal eye drops and antiviral and analgesic medication orally.Symptoms were continuing.Additional info has been requested but not yet available.

Manufacturer Narrative

H.3., h.6.: the actual complaint product was not returned for evaluation.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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The previous report submitted for this event contained an error in h1 ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h1 on a select number of reports.The error, which was limited only to the h1 field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX AQUA MULTIFOCAL
• 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: 11387162
• MDR Text Key: 234637317
• Report Number: 3006186389-2021-00004
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: CBV92003420
• Device Lot Number: 10405082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 55 YR