MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-21 for 23GA COMBINED VITRECTOMY PACK WITH VALVES AND AFI&WF BL5525WVX manufactured by Bausch + Lomb.
[184173231]
A lot number was not provided; therefore, the sterilization and lot history records could not be reviewed. Investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[184173232]
The user facility in (b)(6) reported a cutter stopped while the aspiration continued. It was replaced with another cutter and the surgery was completed. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001920664-2020-00033 |
| MDR Report Key | 9741026 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-21 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-31 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-21 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 23GA COMBINED VITRECTOMY PACK WITH VALVES AND AFI&WF |
| Generic Name | UNIT, PHACOFRAGMENTATION |
| Product Code | HQE |
| Date Received | 2020-02-21 |
| Model Number | BL5525WVX |
| Catalog Number | BL5525WVX |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-02-21 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |