MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2020-03-11 for 25G BI-B COMBINED ELITE W WF SE5525WVB manufactured by Bausch + Lomb Inc.
[183356494]
Manufacturing and sterilization records for se5525wvb, lot w5117 were reviewed and found to be acceptable. Due to covid19 outbreak, hospitals are discouraged from releasing used products. For this reason the product will not be returned and will therefore not be evaluated. Further investigation is underway.
Patient Sequence No: 1, Text Type: N, H10
[183356495]
A user facility in (b)(6) reported that a cutter was not cutting well. Cutting stopped and aspiration continued though the surgeon stopped aspiration as soon as the cutter stopped cutting and aspiration continued. The surgeon asked the nurse to change to another pack. Surgery was completed with no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001920664-2020-00052 |
| MDR Report Key | 9821712 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-16 |
| Date of Event | 2020-02-16 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 | 25G BI-B COMBINED ELITE W WF |
| Generic Name | UNIT, PHACOFRAGMENTATION |
| Product Code | HQC |
| Date Received | 2020-03-11 |
| Model Number | SE5525WVB |
| Catalog Number | SE5525WVB |
| Lot Number | W5117 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB INC |
| Manufacturer Address | 1400 N GOODMAN ST ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-03-11 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |