FDA Device recall Z-1746-2013
nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by catara…
- FDA Device
- Class II
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class II recall of nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by catara… by Staar Surgical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1746-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-10 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Staar Surgical |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: B377007 B377125 B377343 B377522 B377622 B377914 B378040 B378215 B377008 B377126 B377347 B377526 B3776…Serial Numbers: B377007 B377125 B377343 B377522 B377622 B377914 B378040 B378215 B377008 B377126 B377347 B377526 B377627 B377915 B378041 B378216 B377009 B377130 B377348 B377531 B377632 B377918 B378042 B378217 B377010 B377131 B377349 B377532 B377635 B377920 B378043 B378218 B377013 B377142 B377350 B377536 B377640 B377921 B378051 B378219 B377016 B377151 B377352 B377538 B377643 B377923 B378053 B378220 B377020 B377153 B377353 B377539 B377650 B377926 B378057 B378222 B377024 B377154 B377354 B377541 B377651 B377936 B378058 B378223 B377025 B377158 B377355 B377542 B377655 B377940 B378059 B378225 B377026 B377161 B377356 B377543 B377660 B377942 B378062 B378227 B377029 B377165 B377357 B377544 B377669 B377943 B378063 B378228 B377030 B377167 B377358 B377548 B377678 B377944 B378065 B378231 B377032 B377168 B377359 B377550 B377681 B377945 B378067 B378234 B377034 B377171 B377360 B377551 B377686 B377946 B378068 B378235 B377035 B377172 B377361 B377552 B377687 B377950 B378070 B378236 B377036 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1746-2013%22
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