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Terminated

MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.

FDA Recall Z-0519-2021 · Posted None

Recalling FirmBausch & Lomb Surgical, Inc.
Recall StatusTerminated
Product CodeMJP
Date Initiated2020-11-07
Date Terminated2024-07-11
Product Quantity31 devices

Reason for Recall

Product may be missing toric axis marks.

Firm Action

The firm initiated the recall by letter on 11/07/2020. The letter requested the consignee review their inventory and quarantine all suspect product. It further requested that the consignee complete the acknowledgement form and contact Bausch & Lomb to obtain a Return Material Authorization Number and arrange for pick up of the devices. Those with questions or concerns regarding the process should call 1-800-338-2020.

Root Cause

Process change control

Distribution Pattern

US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.

Official Source

View FDA Recall →

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

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