Afinity CQ2015A Intraocular Lens The visual correction of aphakia in… — Class II medical device recall Z-1747-2013
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-1747-2013 |
|---|---|
| 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 | B377178, B377192, B377193, B377194, B377195, B377196, B377197, B377200, B377205, B377208, B377211, B377213, B377214, B377216, B377217, B377232, B377236, B377238, B377239, B377241, B377243, B377245, B377248, B377249, B377253 and 475 more |
Product
Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1747-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.