FDA Adverse Event
Injury
Summary report: N
ACUVUE 2
MDR report key: 21805875
·
Received April 9, 2025
Report
- Report Number
- MW5168738
- Event Type
- Injury
- Date Received
- April 9, 2025
- Report Date
- April 8, 2025
- Manufacturer
- JOHNSON & JOHNSON VISION CARE, INC.
- Product Code
- LPL
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ONE BROKEN LENS FROM THE BOXES I ORDERED. LEFT EYE / BC / DIA / (8.3/14.0) / PWR (-1.50) (B)(6) AFTER I TRIED ONE LENS, I FOUND OUT THAT MY LEFT EYE WAS WATERING AND BECAME VERY RED AND IRRITATED. WHEN I TOOK THE LENS OUT, AND I SAW TWO MICRO CUTS ON THE LENS. IT WAS A DEFECTIVE BATCH. WHEN I CONTACTED THE COMPANY ABOUT THE WORRY I HAVE TOWARDS THE LENS, THEY WERE RUDE AND NOT HELPFUL AT ALL. THE SAME ISSUE I HAVE EXPERIENCED BEFORE TOO, BUT I DIDN'T ASK FOR ANY REFUND OR REPLACEMENT. THIS TIME, I FILED THE COMPLAINT, AND THEY WERE VERY RUDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1814948 | ACUVUE 2 | LENSES, SOFT CONTACT, DAILY WEAR | LPL | JOHNSON & JOHNSON VISION CARE, INC. | L005ZVF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |