MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2011-07-13 for BASIC VENTURI PHACO PACK DP4305 manufactured by Bausch & Lomb, Inc..
[2128783]
Report received from france stating "various bubbles on irrigation/aspiration. No pt impact. "
Patient Sequence No: 1, Text Type: D, B5
[9217131]
The device has not been returned for eval. Sterilization and lot history records were reviewed and no exceptions were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2011-00089 |
| MDR Report Key | 2193265 |
| Report Source | 01,05,07 |
| Date Received | 2011-07-13 |
| Date of Report | 2011-06-16 |
| Date of Event | 2011-06-16 |
| Date Mfgr Received | 2011-06-16 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2011-09-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON TRELFORD, DIRECTOR |
| Manufacturer Street | 30 ENTERPRISE STE 450 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493891786 |
| Manufacturer G1 | BAUSCH & LOMB, INC. |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 63122669 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63122 6694 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BASIC VENTURI PHACO PACK |
| Product Code | MSR |
| Date Received | 2011-07-13 |
| Catalog Number | DP4305 |
| Lot Number | U5290 |
| Device Expiration Date | 2012-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-13 |