Class II — Johnson & Johnson Surgical Vision Inc
| Recalling firm | Johnson & Johnson Surgical Vision, Inc. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Expired intraocular lenses were distributed. |
| 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. |
| 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. |
| Initiated | 2018-06-21 |
| Classified | 2018-11-14 |
| Terminated | 2021-04-28 |
| Recall number | Z-0464-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Johnson & Johnson Surgical Vision Inc (Z-0464-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81408/
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