International safety notice
Alert 2980 (Technovigilance) - Eckert & Ziegler Brasil Comercial Ltda - Ruthenium Ophthalmic Applicators - 106 Deviation of the certified dose in relation to the correct value in specific serial numbers.
Brazil / Anvisa · BRA · Aug 28, 2019
Key facts
| Title | Alert 2980 (Technovigilance) - Eckert & Ziegler Brasil Comercial Ltda - Ruthenium Ophthalmic Applicators - 106 Deviation of the certified dose in relation to the correct value in specific serial numbers. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Ruthenium Ophthalmic Applicators - 106 Technical Name: Ophthalmic Implant ANVISA registration number: 80012590223 Risk Class: III Affected model: Ruthenium-106 Ophthalmic Applicators CCB; Affected serial numbers: Series CCB 2735; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ECKERT ZIEGLER BRASIL COMERCIAL LTDA CNPJ 02887124000166 RUA CAMPOS SALLES BARUERI SP TEL 11 3526 5761 EMAIL CLARICEALMEIDAEZAGCOM FABRICANTE DO PRODUTO ECKERT ZIEGLER BEBIG GMBH ROBERTROSSLESTR 10 13125 BERLIN ALEMANHA |
| Models | 80012590223, Rutênio-106 |
| Date | Aug 28, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1