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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined MidField Elite Pack

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  Class 2 Device Recall Bausch Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined MidField Elite Pack see related information
Date Initiated by Firm August 08, 2018
Create Date September 27, 2018
Recall Status1 Terminated 3 on August 28, 2019
Recall Number Z-3274-2018
Recall Event ID 80837
510(K)Number K162342  
Product Classification Instrument, vitreous aspiration and cutting, ac-powered - Product Code HQE
Product Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
Code Information Lot numbers W0783, exp. 5/11/2019; W0872, exp 6/4/2019; W1107, exp. 7/5/2019; and W1224, exp. 7/21/2019; UDI 00757770059454. 
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
3365 Tree Court Industrial Blvd
Saint Louis MO 63122-6615
For Additional Information Contact Kaylean Premeaux
949-398-5626
Manufacturer Reason
for Recall		 The back cap separates from the body of the vitrectomy cutter.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Recall letters flagged URGENT MEDICAL DEVICE VOLUNTARY RECALL dated 8/8/2018 were issued 8/8/2018 via certified mail return receipt to the U.S. consignees. Letters for foreign consignees were dated 8/7/2018 and were flagged URGENT FIELD SAFETY NOTICE.
Quantity in Commerce 39.33 cases
Distribution Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.
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 = HQE and Original Applicant = Bausch + Lomb
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