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 |