Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Custom Pak (Custom Pak in which Alcon 25 TOTALPLUS Vitrectomy Pak is a component.)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Custom Pak (Custom Pak in which Alcon 25 TOTALPLUS Vitrectomy Pak is a component.) see related information
Date Initiated by Firm January 12, 2018
Create Date February 28, 2018
Recall Status1 Terminated 3 on February 04, 2022
Recall Number Z-0779-2018
Recall Event ID 79226
510(K)Number K101285  
Product Classification Unit, phacofragmentation - Product Code HQC
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.
Code Information Lot 507492, 507664, 507539
Recalling Firm/
Manufacturer		 Alcon Research, LTD.
9965 Buffalo Speedway
Houston TX 77054-1309
For Additional Information Contact Alcon Customer Service
713-668-9100
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQC and Original Applicant = ALCON MANUFACTURING, LTD.
-
-