Akreos® AO IOL MI60LRecalls & reported problems
Bausch & Lomb Incorporated · Akreos AO Micro Incision Lens +19.00D · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770502841), received between Nov 28, 2016 and Nov 28, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Material Opacification1
Patient problems
- Corneal Edema1
- Insufficient Information1
- Macular Edema1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2016Material Opacification; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Material Opacification; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
THE CONSUMER REPORTED CLOUDY VISION POST BILATERAL IMPLANTS. REPORTEDLY, A YAG PROCEDURE WAS PERFORMED, BUT IT DID NOT IMPROVE HER VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. THIS REPORT REFERENCES THE PATIENT'S LEFT EYE.
Patient problems: Corneal Edema; Insufficient Information; Macular Edema; Visual Impairment
MAUDE report 6130199 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page