AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primar
FDA device recall Z-1123-2014 · posted 2014-03-03 · Terminated
Recall details
- Recalling firm
- AMO Puerto Rico Manufacturing, Inc.
- Reason for recall
- Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
- Action taken
- Beginning on January 28, 2014, AMO began distribution of the Recall Notification Letter to the 72 AMO TECNIS IOL customer accounts within the United States who had received lenses from the 2 affected P/O's. 100% delivery of the recall communication to US customers was confirmed on January 31, 2014. Included with the Recall Notification Letter is a facsimile delivery confirmation which each customer is instructed to fax back to AMO.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HQL
- Quantity affected
- 169 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.
- Date initiated
- 2014-01-28
- Date posted
- 2014-03-03
- Date terminated
- 2017-04-19
- Location
- Anasco, PR
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