Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as f...
FDA Device Recall #Z-2981-2018 — Class III — July 3, 2018
Recall Summary
| Recall Number | Z-2981-2018 |
| Classification | Class III — Low risk |
| Date Initiated | July 3, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alden Optical |
| Location | Lancaster, NY |
| Product Type | Devices |
| Quantity | 36 vials |
Product Description
Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontToric) Zenlens TPC + MV- (Toric Peripheral Curve+Microvault). Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.
Reason for Recall
Vials labeled for the prescriptions contained incorrect lenses
Distribution Pattern
US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.
Lot / Code Information
Lot Number/ Serial Number B3235820 UDI- (01)00785811435660/(10)18101PTC008 B3237820 UDI- (01)00785811435660/(10)18101PTC008 B3240210 UDI-(01)00785811435660/(10)18101PTC008 B3235420 UDI-(01)00785811435660/(10)18101PTC008 B3238610 UDI-(01)00785811435660/(10)18101PTC008 B3238620 UDI-(01)00785811435660/(10)18111PTC001 B3239510 UDI-(01)00785811435660/(10)18101PTC008 B3239520 UDI-(01)00785811435660/(10)18111PTC001 B3238210 UDI-(01)00785811435660/(10)18101PTC008 B3238220 UDI-(01)00785811435660/(10)18101PTC008 B3240510 UDI-(01)00785811435660/(10)18101PTC008 B3240520 UDI-(01)00785811435660/(10)18101PTC008 B3240720 UDI-(01)00785811435660/(10)18101PTC008 B3238510 UDI-(01)00785811435660/(10)18101PTC008 B3238710 UDI-(01)00785811435660/(10)18101PTC008 B3239620 UDI-(01)00785811435677/(10)18116PTC004 B3238120 UDI-(01)00865576000218/(10)P004732 B3225210 UDI-(01)00785811435660/(10)18101PTC008 B3225410 UDI-(01)00785811435660/(10)18101PTC008 B3225420 UDI-(01)00785811435660/(10)18101PTC008 B3239910 UDI-(01)00865576000201/(10)N003062 B3239920 UDI-(01)00865576000201/(10)N003062 B3236610 UDI-(01)00785811435660/(10)18101PTC008 B3240320 UDI-(01)00785811435660/(10)18101PTC008 B3238410 UDI-(01)00785811435660/(10)18101PTC008 B3238810 UDI-(01)00785811435677/(10)18116PTC004 B3238820 UDI-(01)00785811435677/(10)18116PTC004 B3235620 UDI-(01)00785811435660/(10)18101PTC008 B3240410 UDI-(01)00785811435660/(10)18101PTC008 B3240420 UDI-(01)00785811435660/(10)18101PTC008 B3235220 UDI-(01)00785811435660/(10)18101PTC008 B3237010 UDI-(01)00785811435677/(10)18116PTC004 B3237020 UDI-(01)00785811435677/(10)18116PTC004 B3236110 UDI-(01)00785811435660/(10)18101PTC008 B3236010 UDI-(01)00785811435660/(10)18101PTC008
Other Recalls from Alden Optical
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2982-2018 | Class III | Zen RC Toric-Gas permeable contact lenses for D... | Jul 3, 2018 |
| Z-0985-2018 | Class II | Alden HP54 Sphere Daily Wear Soft contact; Cata... | Nov 3, 2017 |
| Z-0988-2018 | Class II | Alden HP54 Toric Daily Wear Soft contact; Catal... | Nov 3, 2017 |
| Z-0989-2018 | Class II | Alden Classic 55 Toric Daily Wear Soft contact;... | Nov 3, 2017 |
| Z-0986-2018 | Class II | Alden HP59 Sphere Daily Wear Soft contact; Cata... | Nov 3, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.