FDA product code · Ophthalmic
HQCUnit, Phacofragmentation
Product code HQC covers Unit, Phacofragmentation, a Class II device regulated under 21 CFR 886.4670. FDA has cleared 316 devices in this code, 3 of them in the last 12 months. Median review time across the 316 most recent decisions is 88 days. openFDA lists 74 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 886.4670
- Review panel
- Ophthalmic
- Clearances
- 316
What is happening in HQC right now?
HQC (Unit, Phacofragmentation) has two findings, most consequential first. 1 first-time filer in the last 12 months, This AG (K250501). The code is crowded, scoring 71 of 100 — 114 companies hold a clearance here and 3 arrived in the last 12 months (HQC:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K250501 |
| Crowding | Context | HQC:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in HQC?
FDA has cleared 316 devices under product code HQC since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+ | Bausch and Lomb | |
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | |
| K250501 | System Sophi | This AG | |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | Carl Zeiss Meditec Cataract Technology, Inc. | |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch and Lomb, Incorporated | |
| K233398 | Faros Surgical System | Oertli Instrumente AG | |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | |
| K232084 | Stellaris Elite vision enhancement system | Bausch and Lomb | |
| K233902 | Centurion Vision System (Active Sentry) (8065753057) | Alcon Laboratories, Inc. |
How long does FDA review take for HQC?
The median FDA review time for HQC is 88 days, measured across the 316 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in HQC?
openFDA lists 74 recall records against product code HQC. A recall record covers one firm's corrective action and may span many device lots.
Z-0305-2026Open, ClassifiedAlcon Research, LLC
Due to incomplete seals in the pouch which provide the sterile barrier.
Z-2109-2025Open, ClassifiedAlcon Research, LLC
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
Z-2646-2024Open, ClassifiedAlcon Research, LLC
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Z-2647-2024Open, ClassifiedAlcon Research, LLC
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Z-2671-2024Open, ClassifiedAlcon Research, LLC
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Showing the 5 most recently initiated of 74. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for HQC?
MAUDE holds 5,711 adverse-event reports naming product code HQC, 1,190 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in HQC unusual?
One month sits above HQC's own expected range: 1 April 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 158 | Insufficient history | No expected range — too little history | |
| 115 | Insufficient history | No expected range — too little history | |
| 138 | Insufficient history | No expected range — too little history | |
| 195 | Insufficient history | No expected range — too little history | |
| 144 | Insufficient history | No expected range — too little history | |
| 145 | Insufficient history | No expected range — too little history | |
| 133 | Insufficient history | No expected range — too little history | |
| 111 | Insufficient history | No expected range — too little history | |
| 164 | Insufficient history | No expected range — too little history | |
| 152 | Insufficient history | No expected range — too little history | |
| 133 | Insufficient history | No expected range — too little history | |
| 345 | Insufficient history | No expected range — too little history | |
| 160 | Insufficient history | No expected range — too little history | |
| 154 | Insufficient history | No expected range — too little history | |
| 134 | Insufficient history | No expected range — too little history | |
| 176 | Insufficient history | No expected range — too little history | |
| 177 | Insufficient history | No expected range — too little history | |
| 194 | Insufficient history | No expected range — too little history | |
| 169 | Insufficient history | No expected range — too little history | |
| 187 | Insufficient history | No expected range — too little history | |
| 177 | Insufficient history | No expected range — too little history | |
| 101 | 46–279 | Within expected (46–279) | |
| 122 | 19–232 | Within expected (19–232) | |
| 81 | 24–261 | Within expected (24–261) | |
| 209 | 69–182 | Above expected (69–182) | |
| 164 | 78–203 | Within expected (78–203) | |
| 122 | 87–219 | Within expected (87–219) | |
| 171 | 120–333 | Within expected (120–333) | |
| 159 | 74–243 | Within expected (74–243) | |
| 161 | 79–256 | Within expected (79–256) | |
| 154 | 80–248 | Within expected (80–248) | |
| 138 | 69–221 | Within expected (69–221) | |
| 207 | 78–239 | Within expected (78–239) | |
| 147 | 103–294 | Within expected (103–294) | |
| 120 | 76–235 | Within expected (76–235) | |
| 149 | 67–249 | Within expected (67–249) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in HQC.
Who has entered HQC in the last year?
One company filed in HQC for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| This AG | K250501 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in HQC?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in HQC?
Across the 316 most recent decisions, these applicants filed most often in HQC.
| Applicant | Recent clearances |
|---|---|
| Storz Instrument Co. | 17 |
| Chiron Vision Corp. | 15 |
| CooperVision, Inc. | 15 |
| Site Microsurgical Systems, Inc. | 14 |
| Abbott Medical Optics, Inc. | 9 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in HQC files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Bausch and Lomb, Incorporated | 15 | 5 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch HQC
Get an email the morning anything changes in HQC — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.