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

Catalog Number CBVUNK00007

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Red Eye(s) (2038); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

This is the second of the two reports for the same patient involving two lot numbers of the same product. Refer to (b)(4) for the reported unknown lot number of the power -500. The complaint sample has not returned for evaluation; the lot number is unknown. 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 from the office of the eye care provider (ecp) on (b)(6) 2018, via telephone, that a female patient experienced eye redness. The patient stated that her eye had an ulcer at one occasion, but still wanted to continue lens wear. Additional information was received on the same day from the patient and confirmed that she experienced eye redness, which was later on developed into corneal ulcer. Medical attention was sought; treatment was unknown. The patient reported that the ulcer and eye redness had resolved, but occasionally was experiencing irritation. This event happened to both of her eyes. No further information can be obtained.

• Brand Name: AIR OPTIX COLORS
• 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
• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 8153626
• MDR Text Key: 130115515
• Report Number: 3006186389-2018-00046
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CBVUNK00007
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/11/2018 Patient Sequence Number: 1