CLASS II Device recall · Reported 12 Nov 2014 · FDA Enforcement Report
Prescription eyeglass safety lenses recalled by Eyemart Express
Eyemart Express is recalling Prescription eyeglass safety lenses, distributed nationwide in the US. The recall was initiated on 12 Sep 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0167-2015
- FDA event ID
- 69345
- Recalling firm
- Eyemart Express, Farmers Branch, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2014
- FDA classified
- 3 Nov 2014
- Reported
- 12 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 12 Sep 2014 | Recall initiated by company | |
| 3 Nov 2014 | Classified by FDA | +52 days |
| 12 Nov 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Prescription eyeglass safety lenses did not meet specifications.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Prescription eyeglass safety lenses. Vision correction
Where it was distributed
Nationwide Distribution including AK, AL, AR, CA, LA, MD, MO, MS, MT, NC, ND, NM, OH, OK, TN, SC, TX, VA, WI, and WV.
Nationwide AlaskaAlabamaArkansasCaliforniaLouisianaMarylandMissouriMississippiMontanaNorth CarolinaNorth DakotaNew MexicoOhioOklahomaSouth CarolinaTennesseeTexasVirginiaWisconsinWest Virginia
Questions about this recall
Why was it recalled?
Prescription eyeglass safety lenses did not meet specifications.
Which lots are affected?
No lot codes are applied. The recalled products contain the following model numbers: LC Elite 1.50 80mm HC, LC Elite 1.50 80mm Suntech GRY, LC Elite Poly 75mm Suntech GRY, LC Elite Poly 77mm HC, LC SFSV 1.67 Suntech3 GRY, LC SFSV 75mm Trivex STG, LC Short Elite Poly 77mm HC, LC Short Elite Poly Suntech GRY, Poly FT-28 with scratch coat, Poly LifeRX Photo FT 7x28 Brown, Poly LifeRx Photo FT-28 Gray, Poly SFSV LifeRx Photo Gray, Poly SFSV with scratch coat, SF SUMMIT ECP 167 TRN7 GY 70mm, SF SUMMIT ECP 167 TRN7 GY 75mm, SF SV 1.53 T7 GY 75mm, SF SV 70mm PHOENIX COT, SFSV 167 Clear, Transitions VI Gray D28
Where was it sold?
Nationwide Distribution including AK, AL, AR, CA, LA, MD, MO, MS, MT, NC, ND, NM, OH, OK, TN, SC, TX, VA, WI, and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |