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

Catalog Number CBVUNK00148

Device Problems Failure to Unfold or Unwrap (1669); Defective Device (2588); Device Handling Problem (3265)

Patient Problems Corneal Abrasion (1789); Eye Pain (4467)

Event Date 11/07/2022

Event Type  Injury  

Manufacturer Narrative

H.3., h.6.: the lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

Event Description

This complaint is in reference to the alcon product air optix plus hydraglyde contact lenses.A consumer reported that lenses were difficult to remove from the eye, edge of lenses were rough and folded.Consumer experienced eye pain and visited the doctor, diagnosed confirmed with abrasion with associated infection in the eye.Consumer discontinued the lenses wear and treated with unknown medication.The current status of the consumer¿s eye was unknown at the time of this report.Additional information has been requested but not yet received.

Manufacturer Narrative

This is a duplicate of manufacturer report number 3006186389-2022-00020, 3006186389-2022-00021.No additional reports will be filed on this report number.Any additional information that is received will be reported on manufacturer report number 3006186389-2022-00020 and 3006186389-2022-00021.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX PLUS HYDRAGLYDE
• 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
• 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17387183
• MDR Text Key: 319654944
• Report Number: 3006186389-2023-00013
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00148
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female