Akreos AOP IOL ADAPTAOP2000Recalls & reported problems
Bausch & Lomb Incorporated · ADAPT-AOP 10.7MM +20.00 · 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 10757770485960), received between Jan 24, 2025 and Apr 17, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Material Opacification1
Patient problems
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2025Material Opacification; Material Opacification
A CONSUMER REPORTED THAT APPROXIMATELY 12 YEARS POST IMPLANTATION THE PATIENT EXPERIENCED DECREASED VISION IN THEIR LEFT EYE AND OPACIFICATION WAS NOTED ON THE IMPLANTED INTRAOCULAR LENS (IOL). THE BCVA MEASUREMENTS WERE NOTED TO BE PRIOR TO THE EVENT 6/7.5 (20/20) AND 6/18 VISION (20/60) AFTER THE OPACIFICATION WAS NOTED. NO SECONDARY TREATMENT WAS REQUIRED TO TREAT THE EVENT AND THE IOL REMAINS IMPLANTED AS THE PATIENTS OTHER IOL REMAINS IN GOOD CONDITION.
Patient problems: Visual Impairment
MAUDE report 21858805 ↗InjuryJan 24, 2025Crack; Crack
ADDITIONAL INFORMATION RECEIVED. WHEN THE IOL WAS REMOVED, A POSTERIOR CAPSULE TEAR OCCURRED. THE PATIENT REQUIRED FURTHER TREATMENT WITHIN THE SAME PROCEDURE.
Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions
MAUDE report 21231549 ↗
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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