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 2020-03-05 for AMVISC PLUS VISCOSURGICAL DEVICE 60081L manufactured by Bausch + Lomb.
[183918313]
Investigation of this event is in progress. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[183918314]
The physician reported that one or more patients have experienced toxic anterior segment syndrome (tass) after intraocular lens (iol) implantation using the viscoelastic. The exact number of patients with tass has not been specified. Treatment administered consisted of para-ocular betamethasone injection with topical prednisolone and cycloplegics, and signs and symptoms responded positively to treatment after a few days. Reportedly after eliminating other potential causes, the physician suspects that tass was likely caused by the viscoelastic. Additional information has been requested but has not been received to date. This report refers to the viscoelastic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00051 |
| MDR Report Key | 9795379 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-05 |
| Date of Report | 2020-02-06 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-03-05 |
| 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 PLUS VISCOSURGICAL DEVICE |
| Generic Name | AID, SURGICAL, VISCOELASTIC |
| Product Code | LZP |
| Date Received | 2020-03-05 |
| Model Number | 60081L |
| Lot Number | 027118 |
| Device Expiration Date | 2020-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-03-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-05 |