Recall Z-0464-2019 ยท HQL Intraocular Lens
Johnson & Johnson Surgical Vision Inc
Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.
| Date | Nov 14, 2018 (initiated Jun 21, 2018) |
| Status | Terminated |
| Reason | Expired intraocular lenses were distributed. |
| Root cause | Process control |
| Action | The recalling firm issued letters dated 6/21/2018 via Federal Express requesting return of the IOL's. |
| Quantity | 17 IOL's |
| Distribution | US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.