enVista Aspire™ IOL EA (REF EAU2350)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Aspire hydrophobic acrylic IOL (non-preloaded) +23.50D · Class 3 · Implant
Data updated Oct 13, 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 10757770608628), received between Feb 4, 2026 and Feb 4, 2026 — 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
- Retinal Tear1
- Scar Tissue1
- Unspecified Eye / Vision Problem1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2026Insufficient Device Problem Information
A CONSUMER REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THEY EXPERIENCED FLUID IN THE EYE FOR APPROXIMATELY 4¿5 MONTHS. ACCORDING TO THE CONSUMER, THE SURGEON PRESCRIBED ANTI-INFLAMMATORY DROPS AND THE FLUID SUBSEQUENTLY RESOLVED. DESPITE THE REPORTED RESOLUTION OF THE FLUID, THE CONSUMER ALLEGED THEY WERE UNABLE TO SEE DISTANCE AND COULD ONLY SEE NEAR. THE CONSUMER STATED THAT A LASER PROCEDURE WAS PERFORMED APPROXIMATELY SEVEN MONTHS POST-OPERATIVELY; HOWEVER, DISTANCE VISION DID NOT IMPROVE FOLLOWING THE PROCEDURE. THE CONSUMER FURTHER REPORTED THAT THE SURGEON INFORMED HER THAT THE REASON FOR THE ONGOING VISUAL ISSUES WAS DUE TO SCAR TISSUE FORMATION IN THE EYE FROM THE PRIOR FLUID ACCUMULATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Retinal Tear; Scar Tissue; Unspecified Eye / Vision Problem; Visual Impairment
MAUDE report 24257678 ↗
Other Intraocular Lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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