AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM
Received Jun 9, 2026 · Event occurred May 21, 2026
Report 3006186389-2026-00027 · MDR key 25441307
Device
Generic name
Extended Wear Soft Contact Lens
Manufacturer
Ciba Vision Johor Sdn, Bhd.Model number
NACatalog number
000000000010125552
Lot number
10724705
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Erosion
- Corneal Abrasion
- Keratitis
- Eye Pain
- Eye Irritation
Narrative
Description of Event or Problem
AS INITIALLY REPORTED BY A NON-HEALTHCARE PROFESSIONAL, THE CONSUMER EXPERIENCED EYE PAIN AND IRRITATION AFTER WEARING THE LENS. THE CONSUMER VISITED A DOCTOR AND WAS DIAGNOSED WITH CORNEAL EPITHELIAL ABRASION AND CORNEAL EROSION. THE PHYSICIAN ALSO NOTED SUPERFICIAL PUNCTATE KERATITIS (SPK). THE CONSUMER WAS PRESCRIBED DIQUAFOSOL SODIUM OPHTHALMIC SOLUTION EYE DROPS AS A MOISTURE AGENT HOWEVER, THE FREQUENCY AND DURATION OF USE WERE NOT SPECIFIED. A FOLLOW-UP VISIT WAS INITIALLY RECOMMENDED. THE CONSUMER SUBSEQUENTLY REVISITED THE DOCTOR, WHO CONFIRMED RECOVERY OF THE EYE. NO FURTHER FOLLOW-UP VISITS WERE ADVISED. THE CURRENT STATUS OF CONSUMER¿S EYE WAS SYMPTOM RESOLVED AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
H.3., H.6.: 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).