FDA Adverse Event
Injury
Summary report: N
THE LIFESTYLE GP MULTIFOCAL CONTACT LENS
MDR report key: 400837
·
Received June 17, 2002
Report
- Report Number
- 2434214-2002-00001
- Event Type
- Injury
- Date Received
- June 17, 2002
- Date of Event
- June 13, 2001
- Report Date
- June 14, 2002
- Manufacturer
- THE LIFESTYLE COMPANY, INC.
- Product Code
- MFK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DR. REPORTED THAT LEFT LENS BROKE IN PT'S EYE CAUSING ABRASIONS WHICH WERE TREATED WITH ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THE LIFESTYLE GP MULTIFOCAL CONTACT LENS | RGP HYDROPHOBIC CONTACT LENS | MFK | THE LIFESTYLE COMPANY, INC. | GP MULTIFOCAL CONTACT LENS | 2402501(MATERIAL) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | CLEANING/DISINFECTING.| BOSTON LENS CARE PRODUCTS USED FOR |