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

Catalog Number CBV92001889

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Microcysts, Epithelial (2232)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 initially reported by the patient that there was physical damage.Additional information was received on 18oct2018 wherein the patient clarified that her physician informed her that there was an epithelial lesion on her right eye.She was prescribed with moxifloxacin hydrochloride/dexamethasone phosphate eye drops for a week.It was mentioned that the patient had recovered from the adverse event.No further information will be available.

Manufacturer Narrative

Device evaluated by mfr:the actual complaint product was not returned for evaluation.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.

• Brand Name: AIR OPTIX AQUA
• 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: 8058812
• MDR Text Key: 126939602
• Report Number: 3006186389-2018-00039
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: CBV92001889
• Device Lot Number: 10324638
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other