Recall Z-0779-2018— Alcon Research, LTD.

Name: FDA recall Z-0779-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-12

Class II · Terminated

Class II FDA medical device recall by Alcon Research, LTD., initiated 2018-01-12, terminated 2022-02-04. It names one FDA 510(k) clearance: K101285. Product: 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: 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..

Recalling firm: Alcon Research, LTD.
Classification: Class II
Status: Terminated
Initiated: 2018-01-12
Terminated: 2022-02-04
Firm location: Houston, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K101285 — CONSTELLATION VISION SYSTEMAlcon Manufacturing, Ltd.·cleared 2010-11-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.