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Panels › Ophthalmic › Product code HQE · Class 2

Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Regulation 886.4150

0510(k)s in 12 months (149 all time)
3recalls in 12 months (37 all time)
35recalls that name a 510(k)
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Top companies in HQE

DateFirm and productCodeLinked 510(k)
Jun 5, 2026D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;
Open, Classified
HQEK213467
Jun 5, 2026D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
Open, Classified
HQEK213467
Jun 5, 2026D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00;
Open, Classified
HQEK213467
Oct 24, 2025Alcon Research LLC
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UN
Open, Classified
HQENone listed
Aug 8, 2018Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays,
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays,
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays,
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
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,
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
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,
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays,
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays,
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays,
Terminated
HQEK162342
Aug 8, 2018Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
Terminated
HQEK162342
Oct 18, 2016Synergetics Inc
25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
Terminated
HQEK121675
Oct 18, 2016Synergetics Inc
25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Terminated
HQEK121675
Oct 18, 2016Synergetics Inc
25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Terminated
HQEK121675
Oct 18, 2016Synergetics Inc
25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Terminated
HQEK121675
Jun 6, 2013Alcon Grieshaber AG
The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
Terminated
HQENone listed
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Angled Needle, Model BL5123A, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
Terminated
HQEK063331
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Needle, Model BL5123, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The pla
Terminated
HQEK063331
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Angled Needle, Model BL5114A, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The
Terminated
HQEK063331
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Model BL5114, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic
Terminated
HQEK063331
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Angled Needle, Model BL5113A, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The
Terminated
HQEK063331
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Needle, Model BL5113, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic
Terminated
HQEK063331
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Stellaris Basic AFS Phaco Pack, Model BL5121, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained in
Terminated
HQEK063331
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Stellaris Premium AFS Phaco Pack, Model BL5120, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained i
Terminated
HQEK063331
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Model BL5112, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench co
Terminated
HQEK063331
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Stellaris Vacuum Phaco Pack, Model BL5111, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained in the
Terminated
HQEK063331
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Model BL5110, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench containe
Terminated
HQEK063331
May 24, 2007Bausch & Lomb Inc
Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other accessories. Catalog #USSCX4920A is also in
Terminated
HQEK980488
May 24, 2007Bausch & Lomb Inc
Bausch & Lomb Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high speed vitrectomy cutter per package. The firm name on the label is Bausch & Lomb incorporated, Rochester, NY.
Terminated
HQEK980488
Apr 21, 2007Bausch & Lomb Inc
Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX4925, containing 1/25-ga. cutter along with accessories, RX. The firm names on the label are Bausch & Lomb Inco
Terminated
HQEK980488
Apr 21, 2007Bausch & Lomb Inc
Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch &
Terminated
HQEK980488

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