FDA Adverse Event
Injury
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 4132688
·
Received September 24, 2014
Report
- Report Number
- 2028159-2014-01773
- Event Type
- Injury
- Date Received
- September 24, 2014
- Date of Event
- August 28, 2014
- Report Date
- August 28, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K112425
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGICAL TECHNICIAN REPORTED THAT A PATIENT EXPERIENCED A CORNEAL BURN DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT. THE BURN WAS MILD AND THERE WAS NO REQUIRED MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 593635 | INFINITI VISION SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI V3.0 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |