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

Catalog Number CBV92071393

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Swelling/ Edema (4577)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not 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.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by an optician, a consumer experienced red eye & corneal ulcer in the right eye, associated with the use of three contact lenses from the same lot number.Additional information was received on 27sep2021 stating that the consumer was seen by an ophthalmologist.Consumer had been wearing contact lenses since 2011, with no issues in either handling or hygiene.On an unknown date in (b)(6) 2021, after the first day of use, 15 days after the 2nd lens, the consumer experienced severe redness, swelling, and irritation.The consumer was diagnosed with two small corneal ulcers and a temporary scar.No culture was collected for analysis.Treatment of the event included temporary cessation of contact lens wear, as well as switching to disposable contact lenses.It was reported that the event had resolved with ¿scar¿ listed as sequela.

Manufacturer Narrative

H3, h6: the complaint product was returned for evaluation and was found to meet manufacturing specifications.Evaluation of retain sample of same batch/lot was also performed and no sign of contamination was found.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 PLUS HYDRAGLYDE FOR ASTIGMATISM
• 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
• 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 12569581
• MDR Text Key: 274791891
• Report Number: 3006186389-2021-00008
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBV92071393
• Device Lot Number: 10505710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Male