CONSTELLATION VISION SYSTEM— 510(k) K101285
Substantially EquivalentAlcon Manufacturing, Ltd.
FDA 510(k) clearance K101285 for CONSTELLATION VISION SYSTEM, Substantially Equivalent on 2010-11-12. Applicant: Alcon Manufacturing, Ltd.. Device class: 2.
Clearance details
- Applicant
- Alcon Manufacturing, Ltd.
- Product code
- Product code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code HQC
view allMore clearances from Alcon Manufacturing, Ltd.
view allAdverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K101285
K-number listed on FDA's recall record- Z-0099-2024 — Constellation Vision System, REF: 8065751150
- Z-1794-2020 — Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
- Z-0778-2018 — Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
- Z-0779-2018 — Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101285.
Data sourced from openFDA. This site is unofficial and independent of the FDA.