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Class 2 Device Recall AMO Tecnis 1Piece Intraocular Lens |
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Date Initiated by Firm |
November 11, 2009 |
Date Posted |
January 12, 2010 |
Recall Status1 |
Terminated 3 on July 25, 2012 |
Recall Number |
Z-0605-2010 |
Recall Event ID |
53781 |
PMA Number |
P980040S015 |
Product Classification |
intraocular lens - Product Code HQL
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Product |
AMO 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
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For Additional Information Contact |
714-247-8656
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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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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PMA Database |
PMAs with Product Code = HQL and Original Applicant = Johnson & Johnson Surgical Vision, Inc.
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