FDA Adverse Event Injury Summary report: N

BIOMEDICS TORIC

MDR report key: 23647727 · Received November 25, 2025

Report

Report Number
MW5179437
Event Type
Injury
Date Received
November 25, 2025
Date of Event
November 20, 2025
Report Date
November 20, 2025
Manufacturer
KITS EYECARE LTD.
Product Code
LPL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

DESCRIBE EVENT, PROBLEM, OR PRODUCT USE ERROR: (B)(6) SUBSTITUTED A BRAND OF CONTACTS THAT HAS CAUSED CYSTIC CORNEAL EDEMA TO MY PATIENT. HER VISION IS CURRENTLY REDUCED TO 20/40 OD AND 20/25 OS; (B)(6) ORDER NUMBER (B)(4); PURCHASE DATE: (B)(6) 2025.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2265301 BIOMEDICS TORIC LENSES, SOFT CONTACT, DAILY WEAR LPL KITS EYECARE LTD.

Patients

Seq Age Sex Outcome Treatment
1 41 YR Female Required Intervention