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

Catalog Number CBVUNK00148

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

Patient Problem Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

As initially reported by an eye care provider (ecp) on (b)(6) 2018, a male consumer experienced several ulcers with his lenses.He was accustomed to wearing a different type of contact lenses without any trouble.The consumer was prescribed with an annual use of contact lenses on the same date the event was reported.Laboratory tests, treatment modalities and the consumer¿s eye condition remains unknown.Additional information has been requested but not yet received.

Manufacturer Narrative

The lot number was not provided and the complaint sample was not made available for evaluation.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.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 (b)(4) for the reported unknown lot number of the involved product with spec -9 or -11 mensual.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
• MDR Report Key: 7676550
• MDR Text Key: 113620781
• Report Number: 3006186389-2018-00023
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K160609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

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 Catalogue Number: CBVUNK00148
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 08/02/2018
• Supplement Dates FDA Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other