| Class 2 Device Recall Bausch Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior MidField Elite Pack | |
Date Initiated by Firm | August 08, 2018 |
Create Date | September 27, 2018 |
Recall Status1 |
Terminated 3 on August 28, 2019 |
Recall Number | Z-3272-2018 |
Recall Event ID |
80837 |
510(K)Number | K162342 |
Product Classification |
Instrument, vitreous aspiration and cutting, ac-powered - Product Code HQE
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Product | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper. |
Code Information |
Lot numbers W0149, exp. 2/26/2019; W0190, exp. 2/28/2019; W0785, exp. 5/11/2019; W0874, exp. 6/4/2019; and W1108, exp. 7/5/2019, UDI 00757770059430. |
Recalling Firm/ Manufacturer |
Bausch & Lomb Inc 3365 Tree Court Industrial Blvd Saint Louis MO 63122-6615
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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 | 67 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 |
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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.
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510(K) Database | 510(K)s with Product Code = HQE
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