Innova Vision, Inc. FDA Record
Innova Vision, Inc. has 0 FDA recalls, 1 inspection, 11 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Innova Vision, Inc." is on file.
- Latest inspection
- Mar 28, 2013 · NAI
- Latest 510(k)
- Apr 17, 2024
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 11 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 28, 2013 | Hsin-Chu, Taiwan | Devices | No Action Indicated (NAI) | 3003746024 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003746024 | Hsin-Chu, Taiwan | 1 | Mar 28, 2013 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K240519 | Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens | Apr 17, 2024 |
| K232139 | Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Nov 16, 2023 |
| K222954 | Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens | Mar 13, 2023 |
| K213119 | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | May 13, 2022 |
| K112373 | CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION | Aug 17, 2012 |
| K083288 | DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER | Sep 3, 2009 |
| K073060 | CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Nov 29, 2007 |
| K062541 | CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | Jun 7, 2007 |
| K053191 | DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS | May 12, 2006 |
| K051129 | DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Aug 12, 2005 |
| K033136 | I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 | Mar 5, 2004 |
Innova Vision, Inc. and the FDA: common questions
Has Innova Vision, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Innova Vision, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Innova Vision, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Innova Vision, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Innova Vision, Inc.?
The most recent FDA inspection on file ended Mar 28, 2013 at Hsin-Chu, Taiwan and was classified NAI. FDA has 1 inspection of Innova Vision, Inc. on file.
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