FDA Recall
Terminated
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.
Recall: Z-0464-2019
·
Initiated June 21, 2018
Recall
- Recall Number
- Z-0464-2019
- Event Number
- 81408
- Firm
- Johnson & Johnson Surgical Vision Inc
- FEI Number
- 3003843509
- Product Code
- HQL
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 21, 2018
- Posted
- November 14, 2018
- Terminated
- April 28, 2021
- Address
- 1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933
Description
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.
Reason
Expired intraocular lenses were distributed.
Action
The recalling firm issued letters dated 6/21/2018 via Federal Express requesting return of the 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.
Quantity
17 IOL's