MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-22 for CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE manufactured by Alcon Research, Llc - Irvine Technology Center.
[188218268]
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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188218269]
A physician reported three patient's experienced a rhexis break capsular rupture following a software update on the system. The surgeon noted that the ultrasounds were too "effective. " this file represents the third of four patients. Additional information has been requested and received. A completed questionnaire was received from the surgeon. Several occlusion phases from handpiece were noted just before posterior capsule rupture in the right eye during the aspiration of quarters of a cataract extraction with intraocular lens (iol) implant surgery. This was 3+ soft subcapsular posterior axial cataract. There was vitreous prolapse and a piece of the cortex fell into the posterior chamber. An anterior vitrectomy was preformed. The case was not completed. The patient was hospitalized and will require an additional posterior vitrectomy to remove the piece of cortex from the posterior chamber and implant the iol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2020-00264 |
| MDR Report Key | 9863731 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-22 |
| Date of Report | 2020-03-22 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE |
| Generic Name | UNIT, PHACOFRAGMENTATION |
| Product Code | HQC |
| Date Received | 2020-03-22 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-22 |