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

Catalog Number CBV92000509

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

It was initially reported on 20sep2018 that a consumer experienced keratitis from wearing contact lens.Further information was received on 26sep2018 from the health care professional inclusive of medical reports following an incident of corneal abrasion and inflammation secondary to particle inside the alleged contact lens.On (b)(6) 2018, the patient used a fresh pair of contact lenses and didn't feel quite right on her right eye (od) but had left the contact lens for an hour.The patient's eye became red, blurry and also experienced pain.Due to untoward symptoms, the patient took the contact lens out and noticed a white particle adhered inside the contact lens that could not be dislodged.On the same date, the patient went to local emergency room and was treated with unknown eye drop but never seen by a physician as she was unable to wait for too long.On (b)(6) 2018, the patient was seen by an eye doctor and reported that her eye was getting worse.The doctor's assessment revealed an abrasion which was full epithelial thickness in the center of her right cornea with significant central corneal haze.Patient's visual acuity was quite reduced at 6/24 (20/80).Furthermore, she was prescribed with moxifloxacin-opthalmic, applied four times a day and inserted a -0.25d bandage lens to provide comfort.On (b)(6) 2018, the patient was seen for follow up.Patient's visual acuity was improved at 6/21 and the epithelium was closed but haze and redness were still noted.It was reported that the bandage lens was removed and patient was instructed to continue moxifloxacin and polyethylene glycol eye drops as lubricant with unknown treatment modality.On (b)(6) 2018, further improvement was seen in patient's visual acuity at 6/12 but there was 'uneven staining' (trace of positive and negative staining) with grade 2 edema with central haze and grade 1-2 injection.On (b)(6) 2018, visual acuity remained at 6/12 but some central haze was still present as well as presence of limbal injection in patient's conjunctiva.On (b)(6) 2018, patient's visual acuity was at 6/9 with varying keratometry and autorefraction readings and still with 'little haze deep in the cornea.' treatment was discontinued.On (b)(6) 2018, the patient was assessed with resolved abrasion along with the haze.Visual acuity was in normal at 6/6.Moreover, patient was advised she could return to contact lens wear and was scheduled for contact lens assessment after 2 weeks.On (b)(6) 2018, the contact lens assessment was normal with visual acuity of 6/6 in each eye.At the time of the report, patient's symptoms have resolved.Additional information has been requested but not yet received.

Manufacturer Narrative

The returned sample (sample 2) has been re-evaluated and found to be defective.A reassessment of the lens at 13x magnification showed a surface abnormality after cleaning of the lens.Further microscopic investigation under higher magnification (150x) confirmed a tiny surface damage in the optic zone of the contact lens.No evidence of particulate/particles embedded or attached to the lens surface was found.This sample was further analyzed using scanning electron microscope and energy dispersive spectrophotometer system.The lens was microscopically and presence of foreign material was observed showing a small size deposit adhered to the lens surface.This deposit was revealed to be a very thin layer of soft, translucent and whitish material adhering to in the inner curve of a lens.Based on the element analysis and visual appearance, the deposit was verified to be chemically identical to the lens material.The deposit of a lens material on the lens surface is a known defect which could originate from the manufacturing process.During manufacturing process, an excessive amount of lens material is used to form the lens.After the lens is formed, the lens is separated from the excessive amount of material, which is called flash.In a very unlikely and very rare cases, small part of the flash can be broken during separation process and transferred to the lens surface where the flash particle adhere and can¿t be removed.Continuous improvements have been implemented in the past years to mitigate the risk of occurrence of the flash particles.As part of quality controls, each individual contact lens undergoes a visual cosmetic inspection under 13x magnification.The flash particle adhering to the lens surface are well detectable under 13x magnification.If such a flash particle is found during this inspection, the lens will be discarded.If the defect is very small, it will be no more visible under 13x magnification.In case the defect has a translucent characteristics, the defect can¿t be easily detected by visual inspection technique.With this justification, no new capa will be initiated.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The complaint product was returned for evaluation and was found to meet manufacturing specifications.The device history record and sterilization record for this 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.The manufacturer internal reference number is: (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
• MDR Report Key: 7989735
• MDR Text Key: 124672434
• Report Number: 3006186389-2018-00035
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: CBV92000509
• Device Lot Number: 10379332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYSTANE ULTRA HYDRATION.; VIGAMOX (ANTIBIOTIC).
• Patient Outcome(s): Other
• Patient Age: 17 YR