Panels › Ophthalmic
Ophthalmic devices
243 product codes reviewed by the Ophthalmic panel. 4,759 510(k) clearances and 972 recalls in the FDA data, 38% of those recalls name a 510(k).
40510(k)s in 12 months
54recalls in 12 months
370recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| HNN | Knife, Ophthalmic | 155 | 1 |
| HQL | Intraocular Lens | 75 | 1 |
| HQC | Unit, Phacofragmentation | 74 | 0 |
| OJK | Eye Tray | 74 | 17 |
| LPL | Lenses, Soft Contact, Daily Wear | 71 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 37 | 3 |
| HQB | Photocoagulator And Accessories | 32 | 4 |
| HQF | Laser, Ophthalmic | 32 | 1 |
| HMX | Cannula, Ophthalmic | 28 | 0 |
| LPM | Lenses, Soft Contact, Extended Wear | 26 | 0 |
| LZP | Aid, Surgical, Viscoelastic | 25 | 1 |
| LPN | Accessories, Soft Lens Products | 23 | 0 |
| MVN | Lens, Contact, (Disposable) | 17 | 1 |
| HNR | Forceps, Ophthalmic | 16 | 13 |
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | 14 | 0 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| OJK | Eye Tray | 2 | 0 | 17 |
| HNR | Forceps, Ophthalmic | 1 | 0 | 13 |
| LPL | Lenses, Soft Contact, Daily Wear | 2 | 11 | 1 |
| HQB | Photocoagulator And Accessories | 2 | 0 | 4 |
| HQC | Unit, Phacofragmentation | 2 | 4 | 0 |
| OBO | Tomography, Optical Coherence | 2 | 3 | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 2 | 3 | 0 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 | 0 | 3 |
| HQF | Laser, Ophthalmic | 2 | 2 | 1 |
| MXY | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | 1 | 0 | 3 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | 2 | 0 |
| HNQ | Hook, Ophthalmic | 1 | 0 | 2 |
| MVN | Lens, Contact, (Disposable) | 2 | 1 | 1 |
| MXK | Device, Analysis, Anterior Segment | 2 | 2 | 0 |
| ORZ | Eyelid Thermal Pulsation System | 2 | 2 | 0 |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | 0 | 1 |
| HJM | Transilluminator, Ac-Powered | 2 | 0 | 1 |
| HKO | Refractometer, Ophthalmic | 1 | 0 | 1 |
| HKX | Tonometer, Ac-Powered | 2 | 1 | 0 |
| HLZ | Electrode, Corneal | 2 | 1 | 0 |
| HMQ | Marker, Sclera | 1 | 0 | 1 |
| HNN | Knife, Ophthalmic | 1 | 0 | 1 |
| HQD | Lens, Contact (Other Material) - Daily | 2 | 1 | 0 |
| HQL | Intraocular Lens | 3 | 0 | 1 |
| LPN | Accessories, Soft Lens Products | 2 | 1 | 0 |
| LRX | Case, Contact Lens | 2 | 1 | 0 |
| LZP | Aid, Surgical, Viscoelastic | 3 | 0 | 1 |
| MLP | Keratoprosthesis, Temporary Implant, Surgical Use | 2 | 1 | 0 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 1 | 1 | 0 |
| MYC | Ophthalmoscope, Laser, Scanning | 2 | 1 | 0 |
| PIB | Diabetic Retinopathy Detection Device | 2 | 1 | 0 |
| QCB | Phakic Toric Intraocular Lens | 3 | 0 | 1 |
| QQJ | Applicator, Negative Pressure, External, Ocular | 2 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | CooperVision, Inc. Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens;
Model/Catalog Number: Softmed Breathables Advanced Toric
Product Description: 55% water content, toric, Open, Classified |
LPL | K160803 K213164 +1 |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D Open, Classified |
OJK | None listed |
| Sep 18, 2026 | CooperVision, Inc. Brand Name: Pearle Vision 1 day
Product Name: (somofilcon A) Contact Lens
Model/Catalog Number: Pearle Vision 1 day Open, Classified |
MVN | K130331 |
| Sep 18, 2026 | Heidelberg Engineering GmbH Brand Name: Heidelberg Engineering GmbH
Product Name: SPECTRALIS with Flex Module
Model/Catalog Number: S3610, S2610, S2000, S1610
multimodal imaging platform optimized for the posterior segment of t Open, Classified |
OBO | K181594 |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
CATARACT PACK
DYNJ59881A Open, Classified |
OJK | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
CATARACT PREOP KIT
DYKS1583A Open, Classified |
OJK | None listed |
| Aug 31, 2026 | Johnson & Johnson Surgical Vision, Inc. HEALON EndoCoat PRO, REF: 10300012 (US/CAN)
HEALON DUET PRO II, REF: 10300016 (US/CAN)
HEALON EndoCoat PRO, REF: 10301012 (EU);
HEALON DUET PRO II, REF: 10301016 (EU) Open, Classified |
LZP | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) EYE KIT, Model Number: DYKM2751;
2) EYE KIT, Model Number: DYKM2751A;
3) CATARACT PREOP KIT, Model Number: DYKS1583A;
4) CATARACT PREOP KIT, Model Number: DYKS1583B Open, Classified |
OJK | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) BASIC PACK , Catalog Number: SBA73BPGCA;
2) SPINE PACK , Catalog Number: SNE11SPHKC;
3) SPINE PACK , Catal Open, Classified |
OJK | None listed |
| Jul 20, 2026 | AVID Medical, Inc. Halyard EYE PACK. Model/Catalog Number: LVEY27
Convenience kit. Open, Classified |
OJK | None listed |
| Jun 29, 2026 | Medline Industries, LP Medline Convenience Kits:
1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A Open, Classified |
OJK | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as:
1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I;
2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J;
3) RETINA LAC/USC CDS, Medline Kit Nu Open, Classified |
OJK | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
BASIC EYE
DYNJ905154I
TUBAL LIGATION CDS
CDS760053K Open, Classified |
OJK | None listed |
| Jun 5, 2026 | D.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 |
HQE | K213467 |
| Jun 5, 2026 | D.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 |
HQE | K213467 |
| Jun 5, 2026 | D.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 |
HQE | K213467 |
| Jun 4, 2026 | SSC- Surgical Specialties Corporation Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL
Model/Catalog Number: 72-2231
Microsurgical Knife Open, Classified |
HNN | None listed |
| May 28, 2026 | Medline Industries, LP Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P Open, Classified |
OJK | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104;
2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A;
3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DY Open, Classified |
OJK | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27 Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25 Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27 Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S Open, Classified |
HNR | None listed |
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