Z-0605-2010

AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)

Name: Z-0605-2010 AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Creator: Abbott Medical Optics Inc (AMO)
Published: 2009-11-11
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2009-11-11 / Terminated / root cause: manufacturing process

FDA source

Abbott Medical Optics Inc (AMO) began a recall of AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00) on 2009-11-11. The reason FDA records is "Abbott Medical Optics (AMO) has received complaints of some Tecnis 1-Piece IOLs (model ZCB00) have adhered to the lens optic after insertion into the eye. This can lead to a need for additional manipulation to separate...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0605-2010
Status: Terminated
Initiated: 2009-11-11
Posted: 2010-01-12
Terminated: 2012-07-25
Recalling firm: Advanced Medical Optics, Inc.
Product: AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Product code: HQL Intraocular Lens
Reason for recall: Abbott Medical Optics (AMO) has received complaints of some Tecnis 1-Piece IOLs (model ZCB00) have adhered to the lens optic after insertion into the eye. This can lead to a need for additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Beginning on Friday, November 6, 2009, AMO began distribution of the Recall Notification Letter via Federal Express to the 874 AMO Tecnis 1-piece IOL customer accounts in the US. Included with the Recall Notification letter is a facsimile delivery confirmation that each customer was instructed to fax back to AMO to confirm receipt of the Recall Notification Letter. --- Beginning on Monday, November 9, 2009, AMO began distribution of the Recall Notification letter to the AMO Tecnis 1-piece IOL customer/distributors accounts outside the USA. "THIS RECALL NOTIFICATION DOES NOT INVOLVE TECNIS 1-PIECE IOL THAT HAVE BEEN IMPLANTED. ONCE THE HAPTICS HAVE BEEN SUCCESSFULLY DEPLOYED, THESE LENSES FUNCTION PROPERLY." Questions should be directed to an AMO Customer Service Representative at 1-877-AMO-4LIFE (1-877-266-4543).
Quantity in commerce: 246000 Lenses
Distribution: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, Hawaii, and Puerto Rico. INTERNATIONAL: Austria, Azerbaijan, Belgium, Canada, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Italy, Lebanon, Lichtenstein, Libya, Martinique, Netherlands, Poland, Palestine, Portugal, Saudi Arabic, Sweden, Slovenia, Turkey, and South Africa.
Product codes and lots: All Serial numbers of tecnis 1-Piece Intraocular Lenses that were processed through lens surface treatment at the AMO PR facility between May 19 and October 16, 2009 - with serial numbers ending in 0906, 0907, 0908, and 0909. and subset with serial numbers ending in 0905 and 0910. Expiration/Use By Date (YYYY-MM): 2011-05, 2011-06, 2011-07, 2011-08, 2011-09, and 2011-10

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)