MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM; EXTENDED WEAR SOFT CONTACT LENS

Catalog Number CBV92071393

Device Problem Defective Device (2588)

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Irritation (1941); Red Eye(s) (2038); Corneal Infiltrates (2231)

Event Date 01/09/2021

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 company representative via telephone on (b)(6) 2021, consumer¿s mom stated that on an unknown date her daughter's eyes became red and irritated.On an unspecified date, they visited nearby eye care professional (ecp) and the ecp stated she had corneal ulcers caused by defective contact lenses.Symptoms resolution was unknown.Additional info has been requested but not yet available.

Event Description

Additional information received on 01feb2021: a form was received and states that patient slept in lenses night before, woke up with the symptoms.Lenses were 1 day old.Patient also reported ice fishing & perhaps around or in smokey environment.Infiltrate is present.Location of the ulcer in left eye was at 7 o'clock mid-periphery and size was 0.5 mm and permanent scaring was noted on the left eye.Right eye was red and there was no ulcer or infiltrate on it.Additional info has been requested but not yet available.As initially reported by a company representative via telephone on (b)(6) 2021, consumer¿s mom stated that on an unknown date her daughter's eyes became red and irritated.On an unspecified date, they visited nearby eye care professional (ecp) and the ecp stated she had corneal ulcers caused by defective contact lenses.Symptoms resolution was unknown.Additional info has been requested but not yet available.

Manufacturer Narrative

Additional information received: based upon the review of the facts available at this time, this complaint is no longer considered serious or reportable.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 PLUS HYDRAGLYDE FOR ASTIGMATISM
• Type of Device: EXTENDED WEAR SOFT CONTACT LENS
• 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: 11266577
• MDR Text Key: 229872873
• Report Number: 3006186389-2021-00002
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBV92071393
• Device Lot Number: 10496530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 02/01/2021; 03/03/2021
• Supplement Dates FDA Received: 03/01/2021; 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other