SofPort® IOL LI61AO (REF LI61AOR2450)Recalls & reported problems
Bausch & Lomb Incorporated · SofPort Silicone Advanced Optics Aspheric Lens +24.50D · Class 3 · Implant
All models of SofPort IOL (20)
Data updated Oct 16, 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 10757770474407), received between Feb 5, 2025 and Feb 5, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Blurred Vision1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2025Break; Break
IT WAS REPORTED APPROXIMATELY THREE MONTHS AFTER IMPLANT OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT PRESENTED WITH BLURRY VISION. THE SURGEON REPORTED AN IOL FRAGMENT WAS OBSERVED ON THE ANTERIOR SURFACE. A SUCCESSFUL LENS EXCHANGE WAS COMPLETED. IN THE SURGEON'S OPINION, THE CAUSE OF THE EVENT IS UNKNOWN, AND THE PATIENT'S OUTCOME IS GOOD.
Patient problems: Blurred Vision
MAUDE report 21312343 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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