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

Catalog Number 000000000010119063

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

Patient Problems Eye Injury (1845); Hypopyon (1913); Eye Pain (4467)

Event Date 02/01/2024

Event Type  Injury  

Event Description

An initially reported by an eye care practitioner who was a consumer family member states that after using lens and lens care products consumer experienced eye injury but its not clear which two products caused.It was also reported that as per the medical record sent by consumer mother confirms white blood cells fluid on front part of eye.Additionally consumer family member reported that erosion on cornea was noted while hanging out on coffee, no further additional information regarding the product and consumer identifiers is known at this time.The current status of consumer¿s eye is unknown.Additional information has been requested but not yet received at the time of report.

Manufacturer Narrative

H.3., h.6.: 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.This is the first of two reports for the same patient involving two different lot numbers of the different product.It is unknown which contributed to the event.Refer to the second report filed under the manufacturer internal reference number of (b)(4).The manufacturer internal reference number is: (b)(4).

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).

• 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: 18900467
• MDR Text Key: 337619094
• Report Number: 3006186389-2024-00007
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 000000000010119063
• Device Lot Number: 10638431
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AOSEPT PLUS HYDRAGLYDE SOLUTION
• Patient Outcome(s): Other
• Patient Sex: Male