FDA recall Z-2552-2020

Bausch & Lomb Surgical, Inc. · Class II · device

Product

enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.

Reason for recall

The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.

Distribution

U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.

Key facts

Status
Terminated
Initiation date
2020-06-09
Report date
2020-07-22
Termination date
2021-02-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Clearwater, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2552-2020