FDA Adverse Event
Injury
Summary report: N
NIGHT & DAY
MDR report key: 1003277
·
Received February 27, 2008
Report
- Report Number
- 9681121-2008-00003
- Event Type
- Injury
- Date Received
- February 27, 2008
- Date of Event
- August 7, 2006
- Report Date
- January 29, 2008
- Manufacturer
- PT CIBA VISION BATAM
- Product Code
- LPM
- PMA / PMN Number
- P010019
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORT WAS REVIEWED BY THE CIBA VISION MEDICAL MONITOR WITH THE FOLLOWING CONCLUSION: "THIS CASE IS CONSIDERED AS AN INFECTIOUS CORNEAL ULCER." AS THERE WAS NO PRODUCT RETURNED OR LOT NUMBER PROVIDED, NO DETAILED INVESTIGATION CAN BE PERFORMED.
Description of Event or Problem · 1
A PATIENT REPORTED HAVING EXPERIENCED SEVERE PAIN AND SWELLING IN HER LEFT EYE ASSOCIATED WITH WEAR OF FOCUS NIGHT & DAY CONTACT LENSES. SHE SOUGHT UNSPECIFIED MEDICAL CARE (DATE NOT PROVIDED), WAS LATER ADMITTED TO A HOSPITAL AND WAS DIAGNOSED WITH A PSEUDOMONAS CORNEAL ULCER. CORNEAL TRANSPLANT IS EXPECTED. REQUEST HAS BEEN MADE FOR ADDITIONAL DETAILS, HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NIGHT & DAY | SOFT CONTACT LENS | LPM | PT CIBA VISION BATAM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R | NONE REPORTED. |