FDA Adverse Event
Injury
Summary report: N
BIOFINITY SPHERE (COMFILCON A )
MDR report key: 2874425
·
Received December 14, 2012
Report
- Report Number
- 9614392-2012-00098
- Event Type
- Injury
- Date Received
- December 14, 2012
- Date of Event
- September 23, 2012
- Report Date
- December 7, 2012
- Manufacturer
- COOPERVISION MANUFACTURING LIMITED
- Product Code
- LPM
- PMA / PMN Number
- P080011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO LENSES WERE RETURNED.
Description of Event or Problem · 1
PATIENT REPORTS ON OR AROUND (B)(6) 2012 HE EXPERIENCED RED IN HIS EYES AND ACHING, LEFT EYE HURT AND HAS A SEVERE INFECTION. CENTRAL LEFT CORNEA, BIG INFECTION THAT COVERS THE PUPIL. THE DOCTOR PRESCRIBED ANTIBIOTICS. THE NEXT DAY ANOTHER DOCTOR CONFIRMS THERE IS A VIRUS AND GIVES THE PATIENT ADDITIONAL SALVES. FOLLOW UP ATTEMPTS FOR MORE INFORMATION HAVE BEEN MADE WITH NO REPLY TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOFINITY SPHERE (COMFILCON A ) | LPM, SOFT CONTACT LENS, EXTENDED WEAR | LPM | COOPERVISION MANUFACTURING LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |