nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years… — Class II medical device recall Z-1746-2013
Terminated recall by Staar Surgical Co., reported 2013-07-24, distributed nationwide. STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lense
| Recall number | Z-1746-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Staar Surgical Co., Monrovia, CA, United States |
| Recall initiated | 2013-06-10 |
| Classified | 2013-07-17 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2013-10-17 |
| Distributed | Nationwide (US) |
| Quantity | 3,361 units |
| Reason classes | foreign material |
| Serial numbers | B377007, B377008, B377009, B377010, B377013, B377016, B377020, B377024, B377025, B377026, B377029, B377030, B377032, B377034, B377035, B377036, B377037, B377038, B377040, B377041, B377042, B377043, B377045, B377049, B377054 and 475 more |
Product
nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.
Reason for recall
STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.