FDA Device recall Z-2859-2016
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aph…
- FDA Device
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aph… by Abbott Medical Optics Amo, citing abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2859-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-26 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Abbott Medical Optics Amo |
| Distribution | US |
Product
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
Reason
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Identifiers
| code_info | Serial No. 2624401411 2624411411 2624421411 2624431411 2624441411 2624451411 2624461411 2624471411 2624481411…Serial No. 2624401411 2624411411 2624421411 2624431411 2624441411 2624451411 2624461411 2624471411 2624481411 2624491411 2624501411 2624511411 2624521411 2624531411 2624541411 2624551411 2624561411 2624571411 2624581411 2624591411 2624601411 2624611411 2624621411 2624631411 2624641411 2624651411 2624661411 2624671411 2624681411 2624691411 2624701411 2624711411 5259101407 5259111407 5259121407 5259131407 5259141407 5259151407 5259161407 5259171407 5259181407 5259191407 5259201407 5259211407 5259221407 5259231407 5259241407 5259251407 5259261407 5259271407 5259281407 5259291407 5259301407 5259311407 5259321407 5259331407 5259341407 5259351407 5259361407 5259371407 5259381407 5259391407 5259401407 5259411407 5259421407 5259431407 5259441407 5259451407 5259461407 5259471407 5259481407 5259491407 5259501407 5259511407 5259521407 5259531407 5259541407 5259551407 5259561407 5259571407 5259581407 5259591407 5259 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2859-2016%22
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