MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for LASER PROBES 8065751593 manufactured by Alcon Research, Llc - Irvine Technology Center.
[141437360]
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
[141437361]
A nurse reported that the laser probe was not able to be inserted into the trocar prior to a vitrectomy procedure.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2028159-2019-00640 |
MDR Report Key | 8492397 |
Date Received | 2019-04-08 |
Date of Report | 2019-09-12 |
Date of Event | 2019-02-19 |
Date Mfgr Received | 2019-09-11 |
Device Manufacturer Date | 2018-09-21 |
Date Added to Maude | 2019-04-08 |
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 | MS. CINDY MILAM |
Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
Manufacturer City | FORT WORTH TX 76134 |
Manufacturer Country | US |
Manufacturer Postal | 76134 |
Manufacturer Phone | 8176152231 |
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 | 0 |
Brand Name | LASER PROBES |
Generic Name | INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED |
Product Code | HQE |
Date Received | 2019-04-08 |
Returned To Mfg | 2019-06-13 |
Model Number | NA |
Catalog Number | 8065751593 |
Lot Number | 18032029X |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
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 | 2019-04-08 |