FDA Device recall Z-2861-2016
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual…
- FDA Device
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual… 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-2861-2016 |
| 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 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 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. 7138841403 2648831412 2648971412 2649011412 2649071412 2649101412 2649181412 2649221412 2649241412…Serial No. 7138841403 2648831412 2648971412 2649011412 2649071412 2649101412 2649181412 2649221412 2649241412 2649261412 2649281412 2649301412 7138301403 7138311403 7138321403 7138331403 7138341403 7138351403 7138361403 7138371403 7138381403 7138391403 7138401403 7138411403 7138431403 7138441403 7138451403 7138461403 7138471403 7138481403 7138491403 7138501403 7138511403 7138521403 7138531403 7138541403 7138551403 7138561403 7138571403 7138581403 7138591403 7138601403 7138611403 7138621403 7138631403 7138641403 7138651403 7138661403 7138671403 7138681403 7138691403 7138701403 7138711403 7138721403 7138731403 7138741403 7138751403 7138761403 7138771403 7138781403 7138791403 7138801403 7138811403 7138821403 7138831403 7138851403 7138881403 7138891403 7138901403 7138911403 7138921403 7138941403 7138951403 7138961403 7138971403 7138981403 7138991403 7139001403 7139011403 7139021403 7139031403 7139041403 7139 |
|---|
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-2861-2016%22
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