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

Catalog Number CBV92027782

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

Patient Problems Pain (1994); Red Eye(s) (2038); Corneal Infiltrates (2231); Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This is the first of two reports for the same patient involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to 2020-20218-01 for the reported lot number 10370827.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

It was reported that the patient experienced discomfort while wearing the complaint contact lenses.She continued to use the contact lenses even though they were uncomfortable.The patient visited an eye care professional (ecp), was diagnosed with corneal ulcer and was prescribed with unknown medications.It was mentioned that the left eye (os) was healed with no residual effects but the patient had not resumed contact lens wear.Additional information was received on 13apr2020 via telephone call.It was reported that the patient had been sleeping with the contact lenses on.Additional information was received on 16apr2020 via fax from the ecp.It was reported that the patient experienced severe pain or discomfort, severe redness and watery and mucopurulent discharge.It was added that there were two infiltrates, however, the location was unknown.The patient was treated with prednisolone drops three times daily.It was mentioned that the event had resolved.Additional information received on 16apr2020 via email.The ecp confirmed that it was a peripheral ulcer.

Manufacturer Narrative

No sample evaluation was performed as sample was not returned.There are no other similar complaints reported on this lot.Investigation has been completed based on current information.Retain sample evaluation was performed as per criteria; visual mantis inspection, vacuum tester for leakage and packaging inspection.The results found that there was no any non-conformance as reported by customer in the 12 pieces of lenses.From the dhr finishing review, there is no any abnormalities observed during the manufacturing of this complaint lot.The lot met the release specification according to manufacturing procedure.The lot has undergone the sterilization process parameter and bi incubation result also met specifications.There is no nonconformance reported during the manufacturing of this lot.No contributing factor identified in the manufacturing investigation.No product return for evaluation therefore no root cause identified for this investigation.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 10011414
• MDR Text Key: 191170360
• Report Number: 3006186389-2020-00004
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K133176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

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: 11/30/2022
• Device Catalogue Number: CBV92027782
• Device Lot Number: 10452433
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other