Recall Z-0605-2010 ยท HQL Intraocular Lens
Abbott Medical Optics Inc (AMO)
AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
| Date | Jan 12, 2010 (initiated Nov 11, 2009) |
| Status | Terminated |
| Reason | 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 | 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- |
| Quantity | 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, Eston |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.