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

Lot Number 10288184

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Irritation (1941); Red Eye(s) (2038); Staphylococcus Aureus (2058); Swelling (2091); Burning Sensation (2146)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

This is the first of two reports for the same patient involving two lot numbers of the same product.Please see additional report submitted under manufacturer internal reference number (b)(4) for a description of the second reported lot number.The complaint sample has been 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.(b)(4).

Event Description

As initially reported via telephone, (b)(6) 2017, a patient experienced red eye in the right eye (od) associated with contact lens wear.She sought for medical treatment and she was told that it was likely allergies.She was prescribed with unspecified allergy drops with unknown duration.The patient resumed contact lens wear after resolution of her symptoms and experienced burning, red eyes, and irritation.She continued contact lens wear until her eye appointment a week after.On (b)(6) 2017, she was diagnosed with a corneal ulcer and staph infection.An unspecified steroid and antibiotic drops with unknown duration were prescribed.Warm compress was performed.On (b)(6) 2017, per follow up visit patient was advised to continue the prescribed drops.(b)(6) 2017, per follow up visit, ecp told her that her symptoms was resolved and she could resume contact lens wear with a new pair of lenses.On (b)(6) 2017, the patient wore another pair of contact lenses from the complaint lot and felt as if the surface of the contact lenses was very dry.She did not wear too much and took them out regularly.Patient stated that around the (b)(6), she noticed that she had developed a lump underneath her eyelid.(b)(6) 2017, per final follow up visit, ecp advised her to discontinue contact lens wear, start drops again and perform warm compress.Patient tried the final pair of contact lenses from the complaint lot on (b)(6) 2017 and her eyes became bloodshot red.After the contact lenses were removed, redness and burning were resolved.Additional information has been requested but not yet received.

Manufacturer Narrative

Correction will be generated for this case to update fda code for the event ¿irritation¿ (b)(4).

Manufacturer Narrative

This is the second of two reports for the same patient involving two lot numbers of the same product.Please see additional report submitted under manufacturer internal reference number (b)(4) for a description of the first reported lot number.Two opened/used complaint samples were received for evaluation.The samples were received unlabeled; however, based on tool code identification, the samples received were confirmed as consistent with both of the reported lot numbers.The two samples were found to meet manufacturing specifications.A retained sample from the same complaint lot (10288184) was tested and was found to meet manufacturing specifications.The device history record and sterilization record for this complaint lot have been reviewed and found to be in compliance.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.(b)(4).

Manufacturer Narrative

Date received by mfr: date was not entered on supplemental device report (smdr) follow-up 2 with file id (b)(4), which was submitted on 19-jan-2018; this smdr (follow-up 3) is being submitted to indicate that this entry should have been 18-dec-2017.

• 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: 6959887
• MDR Text Key: 89686550
• Report Number: 3006186389-2017-00080
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• 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: 10288184
• Other Device ID Number: 000000000010036038-155670800
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other