Akreos AOP IOL ADAPTAOP2350Recalls & reported problems
Bausch & Lomb Incorporated · ADAPT-AOP 10.5MM +23.50 · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770486035), received between Jun 26, 2025 and Aug 19, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Eject” (1 report).
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure to Eject1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- Red Eye(s)1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2025Failure to Eject; Failure to Eject
THE HEALTH CARE FACILITY REPORTED DURING AN INTRAOCULAR LENS IOL IMPLANT PROCEDURE, THE LENS HOOKED IN THE INJECTOR. THE PROCEDURE TIME WAS PROLONGED BY APPROXIMATELY 20 MINUTES AND WAS COMPLETED WITH A DIFFERENT MODEL IOL, A CAPSULAR TENSION RING AND A SULCUS-SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22837368 ↗InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING AN UNCOMPLICATED INTRAOCULAR LENS (IOL) IMPLANTATION IN THE LEFT EYE, THE PATIENT PRESENTED WITH DECREASED VISUAL ACUITY, RED EYE, POSITIVE TYNDAL'S AND SUSPECTED TASS. FIVE (5) DAYS POST PROCEDURE, A SECONDARY INTERVENTION WAS PERFORMED AT ANOTHER HEALTHCARE FACILITY AND THE IOL WAS EXPLANTED AND REPLACED WITH AN UNKNOWN IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Red Eye(s); Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 22335616 ↗
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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