Recall Z-0464-2019— Johnson & Johnson Surgical Vision Inc
Class II · Terminated
Class II FDA medical device recall by Johnson & Johnson Surgical Vision Inc, initiated 2018-06-21, terminated 2021-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Johnson & Johnson Surgical Vision Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-21
- Terminated
- 2021-04-28
- Firm location
- Santa Ana, CA, United States
Product 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 for recall
Expired intraocular lenses were distributed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.