PRECISION7 FOR ASTIGMATISM
Received Apr 21, 2026
Report 9610813-2026-00016 · MDR key 24934379
Device
Generic name
Lenses, Soft Contact, Extended Wear
Manufacturer
Ciba Vision GmbhModel number
NACatalog number
000000000010220361
Lot number
N4180941
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Corneal Ulcer
- Discomfort
Narrative
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).
Description of Event or Problem
AS INITIALLY REPORTED BY A NON¿HEALTHCARE PROFESSIONAL, THE CONSUMER EXPERIENCED A COMFORT ISSUE AND DEVELOPED AN ULCER IN THE LEFT EYE AFTER THREE TO FOUR WEEKS OF CONTACT LENS USE. FOLLOWING THIS, THE PATIENT DISCONTINUED LENS WEAR, AFTER WHICH THE CONSUMER¿S VISION RETURNED TO NORMAL, AND THE CONSUMER WAS REPORTED TO BE DOING WELL. THE CONSUMER HAS SINCE RESUMED CONTACT LENS USE WITH LENSES FROM ANOTHER COMPANY WITHOUT ISSUES, AND THE RIGHT EYE REMAINED UNAFFECTED THROUGHOUT. THE CURRENT STATUS OF THE CONSUMER¿S EYE WAS THAT SYMPTOMS RESOLVED AT THE TIME OF THIS REPORT. NO ADDITIONAL INFORMATION HAS BEEN REQUESTED.