Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx
FDA device recall Z-0464-2019 · posted 2018-11-14 · Terminated
Recall details
- Recalling firm
- Johnson & Johnson Surgical Vision Inc
- Reason for recall
- Expired intraocular lenses were distributed.
- Action taken
- The recalling firm issued letters dated 6/21/2018 via Federal Express requesting return of the IOL's.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HQL
- Quantity 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.
- Date initiated
- 2018-06-21
- Date posted
- 2018-11-14
- Date terminated
- 2021-04-28
- Location
- Santa Ana, CA
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