Recall Z-1123-2014— AMO Puerto Rico Manufacturing, Inc.
Class II · Terminated
Class II FDA medical device recall by AMO Puerto Rico Manufacturing, Inc., initiated 2014-01-28, terminated 2017-04-19. FDA's recall record names no specific 510(k) clearance for this event. Product: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.. Reason: Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power..
- Recalling firm
- AMO Puerto Rico Manufacturing, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-28
- Terminated
- 2017-04-19
- Firm location
- Anasco, PR, United States
Product description
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.
Reason for recall
Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
Data sourced from openFDA. This site is unofficial and independent of the FDA.