Z-1933-2010

Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554 The Constellation Vision...

Name: Z-1933-2010 Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554 The Constellation Vision...
Creator: Alcon Research LTD dba Alcon Laboratories, Inc.
Published: 2010-04-30
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2010-04-30 / Terminated / root cause: software

FDA source

Alcon Research LTD dba Alcon Laboratories, Inc. began a recall of Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554 The Constellation Vision System is an ophthalmic microsurgical system that is... on 2010-04-30. The reason FDA records is "Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1933-2010
Status: Terminated
Initiated: 2010-04-30
Posted: 2010-07-13
Terminated: 2011-09-19
Recalling firm: Alcon Laboratories
Product: Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Product code: HQC Unit, Phacofragmentation
Reason for recall: Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system. For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.
Quantity in commerce: 824 units total
Distribution: Worldwide distribution.
Product codes and lots: All lot/serial numbers

Product code HQC

K063583Class IIAlcon Vision SystemAlcon / cleared 2008-05-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)