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.
Reported: November 21, 2018 Initiated: June 21, 2018 #Z-0464-2019
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.
Details
- Recalling Firm
- Johnson & Johnson Surgical Vision Inc
- Units Affected
- 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.
- Location
- Santa Ana, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Johnson & Johnson Surgical Vision Inc. Units affected: 17 IOL's.
Why was this product recalled? ▼
Expired intraocular lenses were distributed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 21, 2018. Severity: Moderate. Recall number: Z-0464-2019.
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