FDA Adverse Event
Injury
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 2143091
·
Received June 23, 2011
Report
- Report Number
- 2028159-2011-00702
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 24, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K082845
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 SURGEON REPORTED DURING A CATARACT EXTRACTION PROCEDURE, HE NOTICED WHITENING OF THE PATIENT'S CORNEA AT THE BEGINNING OF THE PROCEDURE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A CORNEAL BURN. NO OCCLUSION BELL WAS HEARD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | OZIL TORSIONAL HANDPIECE |