MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-06-30 for ADVANCED FLOW SYSTEM PACK CX5310 manufactured by Bausch & Lomb.
[1162942]
Following cataract surgery, the pt developed endophthalmitis one day post-op, and an evisceration of the eye was performed. The cause cannot be determined; however, the cause is not likely due to the device.
Patient Sequence No: 1, Text Type: D, B5
[8436547]
See mdr 1920664-2009-00146 for the intraocular lens, and mdr 1920664-2009-00148 for the viscoelastic used with this disposable pack. A review of our complaint system indicated no other reports for this lot have been recorded. The sterilization and lot history records were viewed and found to be acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2009-00147 |
| MDR Report Key | 1409236 |
| Report Source | 06 |
| Date Received | 2009-06-30 |
| Date of Report | 2009-06-02 |
| Date of Event | 2009-04-16 |
| Date Mfgr Received | 2009-06-02 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2009-07-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET LACAVICH |
| Manufacturer Street | 3365 TREE CT INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 631226694 |
| Manufacturer Country | US |
| Manufacturer Postal | 631226694 |
| Manufacturer Phone | 6362263213 |
| Manufacturer Street | 21 PARK PLACE BLVD N |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33759 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCED FLOW SYSTEM PACK |
| Product Code | MSR |
| Date Received | 2009-06-30 |
| Catalog Number | CX5310 |
| Lot Number | U1440 |
| Device Expiration Date | 2010-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-06-30 |