Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy proce...

FDA Device Recall #Z-0778-2018 — Class II — January 12, 2018

Recall Summary

Recall Number Z-0778-2018
Classification Class II — Moderate risk
Date Initiated January 12, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alcon Research, LTD.
Location Houston, TX
Product Type Devices
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

Lot / Code Information

2060953H

Other Recalls from Alcon Research, LTD.

Recall # Classification Product Date
Z-2408-2023 Class II Infinity FMS Pak Jun 28, 2023
Z-2407-2023 Class II Centurion FMS Pak Jun 28, 2023
Z-2406-2023 Class II Constellation Procedure Pak Jun 28, 2023
Z-2410-2023 Class II Phaco Standalone Tips Jun 28, 2023
Z-2411-2023 Class II Alcon Custom Pak Jun 28, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.