MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2006-03-20 for BASIC VENTURI PHACO PACK DP4305E manufactured by Bausch & Lomb, Inc..
[16786967]
During a posterior polar cataract extraction procedure, a loss of aspiration through this basic venturi pack resulted in a corneal burn to the pt. Additionally, an iris prolapse occurred, the posterior or capsule ruptured and a cataract fragment was lost into the vitreous. Stuches were required to close the wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-2006-00015 |
| MDR Report Key | 689918 |
| Report Source | 05,06,07 |
| Date Received | 2006-03-20 |
| Date of Report | 2006-02-21 |
| Date of Event | 2006-02-08 |
| Date Mfgr Received | 2006-02-21 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-03-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JACKIE FLACH |
| Manufacturer Street | 3365 TREE CT INDUSTRIAL BLVD |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263235 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BASIC VENTURI PHACO PACK |
| Generic Name | OPTHTHALMIC MICROSURGICAL ASSESSORY PACK |
| Product Code | MSR |
| Date Received | 2006-03-20 |
| Model Number | NA |
| Catalog Number | DP4305E |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2007-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 679093 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | * ROCHESTER NY 14609 US |
| Baseline Brand Name | BASIC VENTURI PHACO PACK |
| Baseline Generic Name | OPHTHALMIC MICROSURGICAL ACCESSORY PACK |
| Baseline Model No | NA |
| Baseline Catalog No | DP4305E |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K980100 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-03-20 |