FDA Adverse Event
Other
Summary report: N
CSI, DAILY WEAR, SPHERE
MDR report key: 229994
·
Received June 29, 1999
Report
- Report Number
- 2015587-1999-00002
- Event Type
- Other
- Date Received
- June 29, 1999
- Report Date
- June 7, 1999
- Manufacturer
- WESLEY JESSEN/PBH LTD.
- Product Code
- LPL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT CLAIMS THAT LENS BROKE UP IN HIS EYE AND HAD TO BE REMOVED. PATIENT CLAIMS THAT IS SUFFERED EYE ABRASIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CSI, DAILY WEAR, SPHERE | CONTACT LENS | LPL | WESLEY JESSEN/PBH LTD. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |