FDA Adverse Event
Injury
Summary report: N
CIBASOFT VISITINT
MDR report key: 2023317
·
Received February 15, 2011
Report
- Report Number
- 2648694-2011-00002
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- January 1, 2010
- Report Date
- February 22, 2011
- Manufacturer
- CIBA VISION PUERTO RICO
- Product Code
- LPL
- PMA / PMN Number
- P820086
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO THE COMPLAINT, THE SUSPECT DEVICE HAS BEEN DISPOSED OFF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE IS UNDETERMINED. INTERNAL CONTROL NUMBER: (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PT THAT SHE EXPERIENCED A "100 PERCENT CORNEAL ABRASION LAST YEAR AND TOOK 8 MONTHS TO HEAL." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIBASOFT VISITINT | LENSES, SOFT CONTACT | LPL | CIBA VISION PUERTO RICO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |