Device recall: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for…
Class II FDA enforcement event 67385. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
AMO Puerto Rico Manufacturing, Inc. started this device recall on 28 Jan 2014. The firm address in the FDA record is in Anasco, PR. FDA put the recall in Class II. FDA event 67385 has 1 product record. The first FDA enforcement report date is 12 Mar 2014. The record gives the status Terminated, with the termination date 19 Apr 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.
Recalling firm
AMO Puerto Rico Manufacturing, Inc., Anasco, PR.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1123-2014 | 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. | 169 units | Class II | Terminated | 12 Mar 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Feb 2026 | Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simp | Device | Class II | 1 |
| 13 May 2014 | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual | Device | Class II | 17 |
Official channels
- FDA enforcement report Z-1123-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 67385. https://recallregister.com/fda/ii/67385/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.
- What quantity of product is in FDA event 67385?
- The FDA record gives this quantity:
169 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.