enVista Aspire™ IOL EA (REF EAU2000)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Aspire hydrophobic acrylic IOL (non-preloaded) +20.00D · 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 10757770608550), received between May 24, 2024 and May 24, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2024Break; Break
IT WAS REPORTED THAT UPON DELIVERY OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE SURGEON NOTICED THE HAPTIC WAS DAMAGED. UNDER MICROSCOPIC EXAMINATION, THE SURGEON DISCOVERED THE VERY TIP OF TRAILING HAPTIC WAS MISSING AND NOT IN THE EYE, IT WAS IN THE INJECTOR CARTRIDGE. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND A SUCCESSFUL INTRAOPERATIVE LENS EXCHANGE WAS PERFORMED USING A BACKUP IOL OF THE SAME MODEL AND DIOPTER. PATIENT OUTCOME IS GOOD. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19392775 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.