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

Lot Number 10220125

Device Problems Microbial Contamination of Device (2303); Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint product has not been received 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.(b)(4).

Event Description

As initially reported by a distributor, a consumer did not experience adverse events with trial contact lenses but started "having problems" (unspecified) when he started using product from the complaint lot reported.Only wearing contact lenses sporadically in order to practice sports, the consumer experienced discomfort in the left eye after using the product in question for ten days.The consumer sought medical attention and was diagnosed with infectious keratitis on (b)(6) 2017.The treating physician prescribed an unspecified eye drop and advised the consumer to suspend contact lens wear for seven days.Further information received from the initial reporter on 04/20/2017 stated that the consumer was still using the unspecified treatment prescribed for the event and that the event was improving.Additional information has been requested but not yet received.

Manufacturer Narrative

The complaint was reassessed and the event coding were changed from sae/infectious corneal ulcer to nsae/keratitis (non-infectious) and nsae/infection (non-specified - moderate) since there was no significant symptoms described in the complaint other than discomfort.This complaint described as "infectious" reported by a distributor in the absence of further information of treatment modality is non indicative of a potential sight threatening microbial keratitis/infectious corneal ulcer as reviewed and approved on (b)(6) 2017 by (b)(6) consult, (b)(6).This report is downgraded as deemed non serious and non reportable at this time.(b)(4).

• Brand Name: AIR OPTIX FOR ASTIGMATISM
• 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
• Manufacturer (Section G): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6547905
• MDR Text Key: 74555900
• Report Number: 3006186389-2017-00031
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Lot Number: 10220125
• Other Device ID Number: 000000000010036248-155670800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other