FDA Adverse Event
Injury
Summary report: N
CENTURION VISION SYSTEM
MDR report key: 3931636
·
Received June 24, 2014
Report
- Report Number
- 2028159-2014-01180
- Event Type
- Injury
- Date Received
- June 24, 2014
- Date of Event
- May 27, 2014
- Report Date
- May 27, 2014
- Manufacturer
- ALCON - IRVIN TECH CTR
- Product Code
- HQC
- PMA / PMN Number
- K121555
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTED THAT LENS MATERIAL FELL FROM THE TIP DURING A CATARACT PROCEDURE. THE PT EXPERIENCED A POSTERIOR CAPSULAR TEAR. THE CASE WAS COMPLETED BY IMPLANTING AN INTRAOCULAR LENS IN THE SULCUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 368936 | CENTURION VISION SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVIN TECH CTR | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other | BALANCED SALT SOLUTION| DUOVISC| PROVISC |