MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-04 for AMVISC VISCOSURGICAL DEVICE 59081L manufactured by Bausch + Lomb.
[177772918]
According to the reporter, no additional information is available for this case. The product lot number is unknown, and the product is not available for evaluation. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[177772919]
A surgeon reported an incident where the product cannula injected viscoelastic into the anterior chamber during surgery. The cannula had come off the syringe. There was no patient injury. The reporting facility indicated that no further information is available for this case and the product lot number is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00025 |
| MDR Report Key | 9667060 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-02-04 |
| 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 | STEPHANIE ANASTASIOU |
| Manufacturer Street | 21 NORTH PARK PLACE BLVD. |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal | 33759 |
| Manufacturer Phone | 7277246659 |
| Manufacturer G1 | LIFECORE BIOMEDICAL |
| Manufacturer Street | 3515 LYMAN BLVD. |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMVISC VISCOSURGICAL DEVICE |
| Generic Name | AID, SURGICAL, VISCOELASTIC |
| Product Code | LZP |
| Date Received | 2020-02-04 |
| Model Number | 59081L |
| Catalog Number | 59081L |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 N. GOODMAN ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-02-04 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |