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

Catalog Number CBVUNK00148

Device Problem Sticking (1597)

Patient Problems Corneal Abrasion (1789); Corneal Ulcer (1796); Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

It was reported by the patient's daughter that the contact lenses were so stuck in the patient's eyes that the patient had to peel them off.The patient had to go to the emergency room and found out that she had a corneal abrasion.The patient went back to the eye care professional (ecp) and the ecp believed that the patient had an allergic reaction and prescribed the patient with an unknown treatment regimen.The patient visited the ecp again and was diagnosed with a corneal ulcer.At the time of this report, the patient's eye status was unknown.Additional information has been requested but not yet received.

Manufacturer Narrative

Device evaluated by mfr: 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.

• 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: 7430067
• MDR Text Key: 105446465
• Report Number: 3006186389-2018-00012
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• 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
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other