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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86721

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 07, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bausch & Lomb Surgical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0519-2021
Recall number
Z-0519-2021
Initiated
November 07, 2020
Classification
Class II
Status
Terminated
Quantity
31 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product may be missing toric axis marks.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may be missing toric axis marks.

Code information

Lot number: 3043816 Serial numbers: 3043816001 3043816002 3043816003 3043816004 3043816005 3043816006 3043816007 3043816008 3043816009 3043816010 3043816011 3043816012 3043816013 3043816014 3043816015 3043816016 3043816017 3043816018 3043816019 3043816020 3043816023 3043816024 3043816025 3043816026 3043816027 3043816028 3043816029 3043816030 3043816031

Distribution pattern

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