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

Catalog Number CBV92037094

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Ulceration (2116); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

This is the first of two reports for the same consumer involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to 2018-73844-02 for the reported second lot number 10363290.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.(b)(4).

Event Description

As initially reported by an eye care professional (ecp) through letter on 26sep2018, the ecp states that the consumer has been a user of air optix night and day contact lenses for a span of time, however, the consumer acquired a package of six contact lenses of air optix hydraglyde for each eye last (b)(6) 2018.After a few days of using the first pair from the package, the consumer reportedly felt discomfort and decided to try another pair, however, the same symptom was experienced so a new pair of lenses was opened.Due to the continuing symptoms, the consumer consulted an eye care professional, it was then found out the cause of the discomfort was an ulceration.The consumer was prescribed with an unspecified treatment regimen by the ecp in which the consumer cordially adhered, and as per the ecp¿s approval, the consumer was again allowed to use contact lenses however the consumer felt the same discomfort upon wearing.Additional information has been requested but not yet received at this time.

Manufacturer Narrative

This is the first of two reports for the same consumer involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to (b)(4) for the reported second lot number 10363290.The complaint product was returned for evaluation and was found to meet manufacturing specifications.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX PLUS HYDRAGLYDE
• 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: 8000957
• MDR Text Key: 124965679
• Report Number: 3006186389-2018-00037
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

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 Expiration Date: 06/30/2022
• Device Catalogue Number: CBV92037094
• Device Lot Number: 10364202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 10/25/2018
• Supplement Dates FDA Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other