Z-0779-2018 Class II Terminated
FDA device recall Z-0779-2018 was initiated by Alcon Research, LTD. on Jan 12, 2018 and is designated Class II. 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+… The recall status is terminated (terminated Feb 4, 2022). Affected quantity: 52 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 7, 2018
- Initiation Date
- Jan 12, 2018
- Termination Date
- Feb 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 units
Product Description
Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) 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
Lot 507492, 507664, 507539
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0779-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026