I-See Vision Technology, Inc. FDA Record
I-See Vision Technology, Inc. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "I-See Vision Technology, Inc." is on file.
- Latest inspection
- Sep 10, 2015 · OAI
- Latest 510(k)
- Apr 15, 2015
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 4 | 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 |
|---|---|---|---|---|
| Sep 10, 2015 | Hsinchu, Taiwan | Devices | Official Action Indicated (OAI) | 3008111539 |
- 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 3008111539 | Hsinchu, Taiwan | 1 | Sep 10, 2015 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K150293 | EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses… | Apr 15, 2015 |
| K082879 | EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Jun 16, 2009 |
| K082880 | EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS | Jun 16, 2009 |
| K082883 | EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR | Jun 16, 2009 |
I-See Vision Technology, Inc. and the FDA: common questions
Has I-See Vision Technology, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "I-See Vision Technology, 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 I-See Vision Technology, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "I-See Vision Technology, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect I-See Vision Technology, Inc.?
The most recent FDA inspection on file ended Sep 10, 2015 at Hsinchu, Taiwan and was classified OAI. FDA has 1 inspection of I-See Vision Technology, Inc. on file, 1 of them classified OAI (official action indicated).
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