FDA Adverse Event
Injury
Summary report: N
FOCUS DAILIES VISITINT
MDR report key: 1910797
·
Received November 23, 2010
Report
- Report Number
- 3003657720-2010-00003
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- October 22, 2010
- Report Date
- October 26, 2010
- Manufacturer
- CIBA VISION (SINGAPORE) PTE LTD.
- Product Code
- LPL
- PMA / PMN Number
- K984273
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
AN EYE CARE PROFESSIONAL REPORTED THAT A CONTACT LENS WEARER EXPERIENCED A CORNEAL ULCER WITH PAIN, RIGHT EYE, ASSOCIATED WITH WEAR OF FOCUS DAILIES VISITANT CONTACT LENSES. THE PT SCRATCHED THEIR RIGHT EYE'S CORNEA WITH THEIR FINGERNAILS WHEN TRYING TO REMOVE THE LENS FRAGMENTS OF A TORN LENS. F/U INFO RECEIVED ON (B)(6) 2010 FROM THE TREATING OPHTHALMOLOGIST STATED AN ULCER, LOCATED PERIPHERAL CORNEA, WAS CAUSED BY THE PT'S FINGERNAILS. TREATMENT CONSISTED OF ANTIBIOTIC EYE DROPS. THE EVENT RESOLVED WITH NO EFFECT ON VISUAL ACUITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOCUS DAILIES VISITINT | DAILY WEAR SOFT CONTACT LENS | LPL | CIBA VISION (SINGAPORE) PTE LTD. | C0144658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | NONE REPORTED. |