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 2020-03-11 for CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE 8065750469 manufactured by Alcon Research, Llc - Irvine Technology Center.
[182991094]
The sample has been received and in-house evaluation 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 additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182991095]
A pharmacist reported a patient experienced a corneal burn at incision edge during cataract extraction surgery. The phacoemulsification (phaco) did not work with the handpiece. The handpiece made "milk" in the patient's lens. The handpiece was removed form the eye and exchanged but the system did not work well. The system was switched to perform a combined vitrectomy/cataract procedure due to a burned cornea and a dislocated fragment that fell into the vitreous cavity. There was corneal melting at closure of the case. The patient was hospitalized. Additional information has been requested but not received. This is one of four reports from this facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2020-00236 |
| MDR Report Key | 9819471 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2018-04-18 |
| Date Added to Maude | 2020-03-11 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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, OZIL TORSIONAL HANDPIECE |
| Generic Name | UNIT, PHACOFRAGMENTATION |
| Product Code | HQC |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-03-04 |
| Model Number | NA |
| Catalog Number | 8065750469 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2020-03-11 |