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U.S. Department of Health and Human Services

Class 2 Device Recall AMO Tecnis 1Piece Intraocular Lens

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 Class 2 Device Recall AMO Tecnis 1Piece Intraocular Lenssee related information
Date Initiated by FirmNovember 11, 2009
Date PostedJanuary 12, 2010
Recall Status1 Terminated 3 on July 25, 2012
Recall NumberZ-0605-2010
Recall Event ID 53781
PMA NumberP980040S015 
Product Classification intraocular lens - Product Code HQL
ProductAMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Code Information 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
Recalling Firm/
Manufacturer		 Abbott Medical Optics Inc (AMO)
1700 E Saint Andrew Pl
Santa Ana CA 92705
For Additional Information Contact
714-247-8656
Manufacturer 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.
FDA Determined
Cause 2		Process design
ActionBeginning 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 Commerce246000 Lenses
DistributionAL, 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = HQL
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