AcrySof IQ Vivity
by Alcon Laboratories, Inc. 82 variants
Ref DAT215.190
Active
CE MDR
Valid until
29 Aug 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberG70 020895 0397 | Date11 Jun 2026 | StatusActive |
Certificates
- G70 020895 0397 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 11 Jun 2026
- Expires
- 29 Aug 2028
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- AcrySof IQ Vivity Toric Extended Vision UV Absorbing IOLs
- Model / reference
- DAT215.190
- Primary DI / UDI-DI
- 00380652425438
- Basic UDI-DI
- 038065GMN000132GV
- EMDN code
- P030102100301 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000016248
- Authorised representative
- Alcon Laboratories Belgium BE-AR-000014721
Other devices from Alcon Laboratories, Inc.
Properties
Other properties (13)
- Sterilise before use: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Sutures: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No