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 desig
Check against the official notice below — it lists the full affected range.
AMO Puerto Rico Manufacturing, Inc. is recalling 77,055 AMO TECNIS CL Foldable Silicone intraocular lenses (IOLs) used for cataract surgery in adults. These lenses, which come in Model Z9002 with OptiEdge design, may have incorrect diopter power labeled on the packaging. The affected lenses were distributed worldwide, including throughout the United States, Puerto Rico, Latin America, Asia Pacific, Canada, Europe, Africa, the Middle East, and Japan, across numerous lot codes.
The recall was issued because the labeling on affected units does not accurately reflect the actual diopter power of the lens. This could result in patients receiving IOLs with different optical properties than intended. The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Units may be labeled with the incorrect diopter power.
Reason for recall: Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan. Quantity: 77,055 IOLs in total Lot/code info: 1006311309 1006881309 1031811311 1032341311 1041171312 1041681312 1042161312 1048341311 1006321309 1006891309 1031821311 1032361311 1041181312 1041701312 1042171312 1048351311 1006331309 1006901309 1031841311 1032381311 1041191312 1041711312 1042181312 1048361311 1006341309 1006911309 1031851311 1032401311 1041201312 1041721312 1042191312 1048371311 1006351309 1006921309 1031861311 1032421311 1041211312 1041741312 1042201312 1048381311 1006361309 1006931309 1031871311 1032431311 1041221312 1041761312 1042211312 1048401311 1006371309 1006941309 1031881311 1032441311 1041231312 1041771312 1042221312 1048421311 1006381309 1006961309 1031891311 1032461311 1041241312 1041781312 1042231312 1048441311 1006391309 1006981309 1031901311 1032481311 1041251312 1041791312 1042241312 1048461311 1006401309 1007001309 1031911311 1032501311 1041261312 1041801312 1042251312 1048481311 1006411309 1007021309 1031921311 1032521311 1041271312 1041811312 1047821311 1048501311 1006421309 1007031309 1031931311 1032541311 1041281312 1041821312 1047841311 1048511311 1006431309 1007041309 1031941311 1032561311 1041291312 1041831312 1047861311 1048521311 1006441309 1007061309 1031951311 1032581311 1041301312 1041841312 1047881311 1048531311 1006451309 1007071309 1031961311 1032591311 1041311312 1041851312 1047901311 1048541311 1006471309 1007081309 1031971311 1032601311 1041321312 1041861312 1047911311 1048551311 1006491309 1007091309 1031981311 1032611311 1041331312 1041871312 1047931311 1048561311 1006
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.