enVista Aspire™ IOL EA (REF EAU1000)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Aspire hydrophobic acrylic IOL (non-preloaded) +10.00D · Class 3 · Implant
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 10757770608352), received between Apr 23, 2025 and Apr 23, 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. How this data works · Data updated Oct 13, 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 · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE PATIENT PRESENTED WITH INCREASED BLURRY VISION. PATIENT HAD ABOUT 3+ CELL BUT NO HYPOPYON. TOPICAL STEROIDS WERE INCREASED AND ON THE NEXT DAY, THE AC CELL WAS SLIGHTLY IMPROVED BUT VISION WAS DECREASED WITH VITREOUS HAZE. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). INTRAVITREAL ANTIBIOTIC INJECTION WERE GIVEN. THE PATIENT IS DOING WELL AND THE VITREOUS HAZE RESOLVED. VISUAL ACUITY CORRECTABLE TO 20/20.
Patient problems: Toxic Anterior Segment Syndrome (TASS); Visual Impairment; Vitreous Floaters
MAUDE report 21894068 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.