enVista Aspire™ Toric IOL ETA (REF ETAU150+260)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Aspire toric hydrophobic acrylic IOL (non-preloaded) +26.00D SE / +1.50D CYL · Class 3 · Implant
All models of enVista Aspire Toric IOL (513)
Data updated Oct 18, 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 10757770621528), received between Jun 11, 2025 and Jun 11, 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 18, 2026.
Reports received per month
Recalls naming this device
- Mar 27, 2025Class IOpen, 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
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hypopyon1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT PRESENTED WITH MODERATE WOUND EDEMA, 4+ CELL, FIBRIN & HYPOPYON. BASED ON THE FINDINGS, THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). AS A PRECAUTION, THE PATIENT WAS IMMEDIATELY REFERRED TO RETINA FOR A CULTURE TO BE PERFORMED AND INTRAVITREAL INJECTIONS OF VANCOMYCIN & CEFTAZIDIME TO BE ADMINISTERED. THE FOLLOWING DAY THE PATIENT HAD AN ADDITIONAL ROUND OF INTRAVITREAL INJECTIONS OF VANCOMYCIN & CEFTAZIDIME. THERE WAS NO GROWTH FROM THE CULTURE. THE INFLAMMATION/TASS HAS FULLY RESOLVED. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE LENS. ACCORDING TO THE SURGEON, PATIENT OUTCOME IS GOOD. ACCORDING TO THE CONSUMER, HER DISTANCE VISION IS BLURRY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypopyon; Toxic Anterior Segment Syndrome (TASS); Visual Disturbances; Visual Impairment
MAUDE report 22187346 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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