Abbott Medical Optics Inc (AMO) AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Brand
Abbott Medical Optics Inc (AMO)
Lot Codes / Batch Numbers
2009 - with serial numbers ending in 0906, 0907, 0908, 2011-06, 2011-07, 2011-08, 2011-09, and 2011-10
Products Sold
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
Abbott Medical Optics Inc (AMO) is recalling AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00) due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, ME, MA, MI, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026