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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.

FDA Recall Z-0464-2019 · Posted 2018-11-14

Recalling FirmJohnson & Johnson Surgical Vision Inc
Recall StatusTerminated
Product CodeHQL
Date Initiated2018-06-21
Date Terminated2021-04-28
Product Quantity17 IOL's

Reason for Recall

Expired intraocular lenses were distributed.

Firm Action

The recalling firm issued letters dated 6/21/2018 via Federal Express requesting return of the IOL's.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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