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 Problem Abscess (1690)

Event Date 07/07/2019

Event Type  Injury  

Manufacturer Narrative

This is the second of two reports for the same patient involving two complaint products from the same product line, but with differing parameters; this report references the complaint product reported with a reported power of +2.5.It is unknown which contributed to the event.Refer to 2019-70106-01 for the reported unknown lot number with power of +4.The lot number was not provided and the complaint sample was not made available for evaluation.No lot number was provided and no sample was returned for evaluation.Due to this, no lot information could be able to be performed.The trend investigation has been completed for this complaint.No any unfavorable trend identified for the entire event related to this complaint for the past months.No any significant of signal or pattern identified in the trend during this review period.The investigation could not identify a root cause to the complaint reported by the customer as no lot number was provided and no sample was returned for evaluation.Therefore, inconclusive-insufficient product or product data was concluded for this reported complaint.Inconclusive-insufficient product or product data was concluded for this reported complaint, hence no capa will be initiated at this moment.The manufacturer internal reference number is: (b)(4).

Event Description

It was reported on 13sep2019 that a patient experienced corneal abscess in the right eye (od) after three or four days of wearing the complaint contact lenses.The treatment modality and symptom resolution were still unknown.Additional information was received on 24sep2019 via a telephone call from the optician.It was reported that the patient tried to wear the complaint contact lenses in (b)(6) 2019 and three days later, the patient reported an abscess to the cornea.

Manufacturer Narrative

D.4.: new information received.H.10.: this report is being submitted to report the new information received regarding the event; the lot number for the left eye (os) was 10360128 with power +4.50 and was confirmed to have not contributed to the reportable event.No further reports are expected for the reported product.

• 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: 9177997
• MDR Text Key: 168778163
• Report Number: 3006186389-2019-00018
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

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: 04/30/2021
• Device Catalogue Number: CBV92027782
• Device Lot Number: 10360128
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other