Staar Surgical Ag - Evo Visian Icl V4c (vicmo) Standard

Recalling firm

Device Technologies New Zealand

Product

STAAR Surgical AG - EVO Visian ICL V4c (VICMO) standard. [Device]. Model: Visian EVO ICL V4c (VICMO) standard; Visian EVO ICL V4c (VTICMO) toric; Visian EVO+ (VICM5) standard; Visian EVO+ (VTICM5) toric; Visian ICL (VICH); Visian Toric ICL (VTICH). Also covers: STAAR Surgical AG - EVO Visian ICL V4c (VTICMO) toric; STAAR Surgical AG - EVO Visian + (VICM5) standard; STAAR Surgical AG - EVO+ Visian ICL (VTICM5) toric; STAAR Surgical - VICH lens; STAAR Surgical - VTICH lens

Reason

The manufacturer has become aware of problems that may affect information displayed on the Implant Orientation Diagram (IOD) that is generated in Stella 2.0. The IOD is used for the implantation of Toric EVO/EVO+ Implantable Collamer Lenses (ICLs)., The identified problems are as follows:, 1. Expected refraction, spherical equivalent, and/or model/version values may be incorrect on the generated IOD., 2. If the sphere value for a Toric lens reservation is null, Stella 2.0 will default to indicate a rotation value of 90° on the IOD., 3. Users' local office network firewall settings may...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-06-12

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/ae54723b-22e1-4b75-86bc-de6b1c2ccc75