Z-0778-2018 Class II Terminated

Recalled by Alcon Research, LTD. — Houston, TX

Recall Details

Product Type
Devices
Report Date
March 7, 2018
Initiation Date
January 12, 2018
Termination Date
February 4, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
300 units

Product Description

Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

Reason for Recall

Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.

Distribution Pattern

Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine

Code Information

2060953H