FDA Device recall Z-1747-2013
Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been r…
- FDA Device
- Class II
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class II recall of Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been r… 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-1747-2013 |
| 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
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
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: B377178 B377469 B377877 B378928 B379032 B379638 B380197 B380796 B377192 B377473 B377879 B378940 B3790…Serial Numbers: B377178 B377469 B377877 B378928 B379032 B379638 B380197 B380796 B377192 B377473 B377879 B378940 B379048 B379643 B380200 B380800 B377193 B377480 B377880 B378945 B379062 B379645 B380206 B380801 B377194 B377481 B377883 B378946 B379063 B379646 B380208 B380803 B377195 B377482 B377885 B378947 B379066 B379650 B380214 B380807 B377196 B377485 B377887 B378949 B379093 B379652 B380227 B380816 B377197 B377487 B377888 B378951 B379095 B379653 B380230 B381000 B377200 B377488 B377889 B378953 B379096 B379660 B380235 B381001 B377205 B377490 B377890 B378954 B379099 B379661 B380245 B381009 B377208 B377491 B377894 B378955 B379100 B380060 B380246 B381011 B377211 B377493 B378097 B378956 B379101 B380070 B380251 B381012 B377213 B377495 B378099 B378957 B379103 B380071 B380257 B381014 B377214 B377496 B378107 B378958 B379104 B380072 B380261 B381017 B377216 B377497 B378110 B378959 B379106 B380073 B380265 B381019 B377217 B377804 B378111 B378960 B379107 B380078 B380270 B381021 B377232 |
|---|
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-1747-2013%22
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