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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.)

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 Class 2 Device Recall Custom Pak (Custom Pak in which Alcon 25 TOTALPLUS Vitrectomy Pak is a component.)see related information
Date Initiated by FirmJanuary 12, 2018
Create DateFebruary 28, 2018
Recall Status1 Terminated 3 on February 04, 2022
Recall NumberZ-0779-2018
Recall Event ID 79226
510(K)NumberK101285 
Product Classification Unit, phacofragmentation - Product Code HQC
ProductCustom 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 ContactAlcon 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
ActionAlcon 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 Commerce52 units
DistributionWorldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HQC
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