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U.S. Department of Health and Human Services

Class 2 Device Recall STAAR AQ CartridgeFP

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  Class 2 Device Recall STAAR AQ CartridgeFP see related information
Date Initiated by Firm May 02, 2016
Create Date June 14, 2016
Recall Status1 Terminated 3 on November 15, 2016
Recall Number Z-1964-2016
Recall Event ID 74067
510(K)Number K940593  
Product Classification Lens, guide, intraocular - Product Code KYB
Product STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
Code Information 1281706, 1282812
Recalling Firm/
Manufacturer
Staar Surgical Co.
1911 Walker Ave
Monrovia CA 91016-4846
For Additional Information Contact
626-303-7902
Manufacturer Reason
for Recall
The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
FDA Determined
Cause 2
Process control
Action STAAR sent a Medical Device Recall Letter dated May 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STAAR Surgical is recalling the STAAR AQ Cartridge-FP because it may malfunction and may crack during loading or delivery of the IOL. Customers with questions are instructed to contact their STAAR customer service representative at (800) 352-7842.
Quantity in Commerce 2,612 units
Distribution US
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 = KYB and Original Applicant = STAAR SUGICAL
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