Product Wiki · Recalls · U.S. FDA — Device Enforcement

AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 16.5, 17.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge d — recall Z-2278-2014

U.S. FDA — Device Enforcement · United States · 2014-05-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2278-2014
Date of alert: 2014-05-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: AMO Puerto Rico Manufacturing, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 1006311309

Reported risk: Units may be labeled with the incorrect diopter power.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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