CLASS II Device recall · Reported 12 Mar 2014 · FDA Enforcement Report
AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design recalled
AMO Puerto Rico Manufacturing is recalling AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design, distributed nationwide in the US. The recall was initiated on 28 Jan 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1123-2014
- FDA event ID
- 67385
- Recalling firm
- AMO Puerto Rico Manufacturing, Anasco, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jan 2014
- FDA classified
- 3 Mar 2014
- Reported
- 12 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 28 Jan 2014 | Recall initiated by company | |
| 3 Mar 2014 | Classified by FDA | +34 days |
| 12 Mar 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.
Questions about this recall
Why was it recalled?
Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
Which lots are affected?
1000001310 1000601310 1230911309 1231211309 1231511309 1231811309 1000011310 1000311310 1000611310 1230921309 1231221309 1231521309 1231821309 1000021310 1000321310 1000621310 1230931309 1231231309 1231531309 1231831309 1000031310 1000331310 1000631310 1230941309 1231241309 1231541309 1231841309 1000041310 1000341310 1000641310 1230951309 1231251309 1231551309 1000051310 1000351310 1000651310 1230961309 1231261309 1231561309 1000061310 1000361310 1000661310 1230971309 1231271309 1231571309 1000071310 1000371310 1000671310 1230981309 1231281309 1231581309 1000081310 1000381310 1000681310 1230991309 1231291309 1231591309 1000091310 1000391310 1000691310 1231001309 1231601309 1000101310 1000401310 1000701310 1231011309 1231311309 1231611309 1000111310 1000411310 1000711310 1231021309 1231321309 1231621309 1000121310 1000421310 1000721310 1231031309 1231331309 1231631309 1000131310 1000431310 1000731310 1231641309 1000141310 1000441310 1000741310 1231051309 1231351309 1231651309 1000151310 1000451310 1000751310 1231061309 1231361309 1231661309 1000161310 1000461310 1000761310 1231071309 1231371309 1000171310 1000471310 1000771310 1231081309 1231381309 1231681309 1000181310 1000481310 1000781310 1231091309 1231391309 1000191310 1000491310 1000791310 1231101309 1231401309 1231701309 1000201310 1000501310 1000801310 1231111309 1231411309 1231711309 1000211310 1000811310 1231121309 1231421309 1231721309 1000221310 1000521310 1000821310 1231131309 1231431309 1000231310 1000531310 1000831310 1231141309 1231441309 1231741309 1000241310 1000541310 1231151309 1231451309 1231751309 1000251310 1000551310 1231161309 1231461309 1231761309 1000261310 1000561310 1231171309 1231471309 1231771309 1000271310 1000571310 1231181309 1231481309 1231781309 1000281310 1000581310 1231191309 1231491309 1231791309 1000291310 1000591310 1231501309 1231801309
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AMO Puerto Rico Manufacturing
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Device Malfunction | Nationwide |
| Device | CLASS II | AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design recalled | AMO Puerto Rico Manufacturing | Other | Nationwide |
| Device | CLASS II | AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design recalled | AMO Puerto Rico Manufacturing | Other | Nationwide |
| Device | CLASS II | AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design recalled | AMO Puerto Rico Manufacturing | Other | Nationwide |
| Device | CLASS II | AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design recalled | AMO Puerto Rico Manufacturing | Other | Nationwide |
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| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Device Malfunction | Nationwide |
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