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

Lot Number 10286266

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Eye Injury (1845); Irritation (1941); Pain (1994); Red Eye(s) (2038); Swelling (2091); Burning Sensation (2146); Ulcer (2274); Discomfort (2330); No Code Available (3191)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

The complaint sample was not made available 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.(b)(4).

Event Description

As reported by the mother of a consumer, on (b)(6) 2016, the consumer experienced slight irritation during wear of the contact lenses.It was reported that the consumer was hospitalized on (b)(6) 2016 for four days, for a corneal abscess in her right eye (od).It was also that reported the consumer was under medical care for several months after the event occurred and suffered tremendous moral injury, light sensitivity and the inability to drive.The condition was treated with drops of di-isétionate hexamidine and hyaluronic acid.Additional information was received via an adverse event (ae) form, on (b)(6) 2016.It was noted in the ae form that consumer experienced irritation/discomfort which included tears, burning, difficulty opening the eye, closed eye, blurry vision, severe redness, severe pain and swelling of eye and eyelid.It was also noted that the symptoms occurred after 5 hours of wearing the lens.The location of the ulcer was noted as ¿top and left¿ and the size of the ulcer was noted as ¿2mmx1.5¿.Hexamidine di-isétionate and hyaluronic acid were prescribed to be administered 1 drop each, every hour (duration of treatment not specified).The corrective treatment which was prescribed included discontinuing contact lens (cl) wear and the use of sunglasses.I was noted that the consumer presented sequela and the issue was still continuing.Additional information has been requested but not yet received.

• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6176663
• MDR Text Key: 62477912
• Report Number: 3006186389-2016-00066
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/14/2016

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: 12/31/2020
• Device Lot Number: 10286266
• Other Device ID Number: 000000000010036935-155670800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 28 YR