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enVista Envy Toric IOLRecalls & reported problems across all models

Bausch & Lomb Incorporated · 513 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names at least one enVista Envy Toric IOL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
39
Deaths reported
0
Injuries reported
39
Recalls
1

We found 513 models of enVista Envy Toric IOL by Bausch & Lomb Incorporated in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Feb 19, 2025 and Sep 24, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 2 reportsMar 2025: 1 reportsApr 2025: 9 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 3 reportsAug 2025: 3 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 4 reportsJan 2026: 4 reportsFeb 2026: 0 reportsMar 2026: 2 reportsApr 2026: 2 reportsMay 2026: 4 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 3 reportsOct 2026: 0 reports2024202520269
Last 36 months. The most recent month may be incomplete.

enVista Envy Toric IOL recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Mar 27, 2025Open, Classified

    In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

    Z-1680-2025 · Root cause: Process control · names 513 of these models · Recall details · FDA record ↗

Most reported enVista Envy Toric IOL problems

Device problems

  • Insufficient Device Problem Information16
  • Adverse Event Without Identified Device or Use Problem13
  • Device Dislodged or Dislocated4
  • Break2
  • Manufacturing, Packaging or Shipping Problem2
  • Unintended Movement2
  • Patient Device Interaction Problem1

Patient problems

  • Toxic Anterior Segment Syndrome (TASS)12
  • Visual Impairment11
  • Visual Disturbances8
  • Halo5
  • Hypopyon5
  • Inflammation5
  • Intraocular Pressure Increased5
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4

enVista Envy Toric IOL models

513 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

Recent enVista Envy Toric IOL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Bausch & Lomb Incorporated products

All Bausch & Lomb Incorporated devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page