ULTRA FOR PRESBYOPIA CONTACTLENS
Received Mar 17, 2026 · Event occurred Jul 9, 2025
Report 0001313525-2026-00016 · MDR key 24621111
Device
Generic name
Lenses, Soft Contact, Daily Wear
Manufacturer
Bausch & Lomb IncorporatedProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Unknown
- Conjunctivitis
- Corneal Edema
- Corneal Scar
- Corneal Ulcer
- Viral Infection
- Eye Infections
- Eye Pain
Narrative
Additional Manufacturer Narrative
ALTHOUGH REQUESTED, THE LOT NUMBER WAS NOT PROVIDED AND THE DEVICE WAS UNAVAILABLE FOR EVALUATION. DUE TO LOT NUMBER NOT BEING PROVIDED UDI IS NOT AVAILABLE AND NO MANUFACTURING INVESTIGATION COULD BE PERFORMED. THE ECP ATTRIBUTED THE EVENT TO THE CONSUMER¿S USAGE OF THE LENS.
Description of Event or Problem
A CONSUMER REPORTED THAT WHILE TRYING A NEW TYPE OF CONTACT LENSES RECOMMENDED BY THEIR EYE CARE PROFESSIONAL, THEY WERE DIAGNOSED WITH BULBAR INJECTION, BULBAR CONJUNCTIVITIS, CORNEAL EDEMA, PARA CENTRAL CORNEAL STAINING, AND AN INFECTIOUS CORNEAL ULCERS WITHIN THE CENTRAL 6 MM OF THE CORNEA IN BOTH EYES. MICROBIAL KERATITIS WAS DIAGNOSED IN BOTH EYES. THE LEFT EYE SHOWED A NEW PARA CENTRAL CORNEAL SCAR WITHIN THE CENTRAL 6 MM. THE CONSUMER WAS TREATED FOR SEVERAL MONTHS WITH FLUOROMETHOLONE AND MOXIFLOXACIN. THE CONSUMER WAS ALSO INSTRUCTED TO NO LONGER SLEEP IN THEIR CONTACTS AND DISCONTINUE CONTACT LENS WEAR. THE PATIENT WAS ALSO INSTRUCTED TO OBTAIN A DIFFERENT LENS DUE TO POOR FIT. THE PATIENT HAS SINCE RECOVERED. THE TREATING PHYSICIAN IDENTIFIED CONTACT LENS OVERUSE AS A POSSIBLE CAUSE OF THE EVENT. THIS REPORT IS FOR THE RIGHT EYE.