enVista Aspire™ IOL EA (REF EAU1950)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Aspire hydrophobic acrylic IOL (non-preloaded) +19.50D · Class 3 · Implant
All models of enVista Aspire IOL (57)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770608543), received between Apr 17, 2025 and Apr 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- 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-1679-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Corneal Edema1
- Hypopyon1
- Intraocular Pressure Increased1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ADDITIONAL INFORMATION WAS OBTAINED FROM THE SURGEON. THE PATIENT IS HIGH PROFILE AND SUTURE WAS NEEDED TO REDUCE THE RISK OF INFECTION. THE PATIENT IS NOW 20/20 UNAIDED, MANIFEST REFRACTION IS PLANO, AND INFLAMMATION HAS RESOLVED.
Patient problems: Corneal Edema; Hypopyon; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 21853463 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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