Z-0779-2018Class II

Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.) Includes all necessary...

Name: Z-0779-2018 Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.) Includes all necessary...
Creator: Alcon Research, LTD.
Published: 2018-01-12
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2018-01-12 / Terminated / root cause: manufacturing process

FDA source

Alcon Research, LTD. began a recall of 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... on 2018-01-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0779-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-12
Posted: 2018-02-28
Terminated: 2022-02-04
Recalling firm: Alcon Laboratories
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.
Product code: HQC Unit, Phacofragmentation
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Alcon sent an Urgent Field Safety Notice Recall notification letters to affected foreign medical users/distributors beginning January 12, 2018. For further questions please call (713) 668-9100.
Quantity in commerce: 52 units
Distribution: Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine
Product codes and lots: Lot 507492, 507664, 507539

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0779-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0778-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0779-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28

Product code HQC

K101285Class IIConstellation Vision SystemAlcon Manufacturing, Ltd. / cleared 2010-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)