SofPort® IOL LI61AO (REF LI61AOR2150)Recalls & reported problems
Bausch & Lomb Incorporated · SofPort Silicone Advanced Optics Aspheric Lens +21.50D · Class 3 · Implant
All models of SofPort IOL (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10757770474346), received between Jul 20, 2024 and Jul 20, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Eject” (3 reports).
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
- Failure to Eject3
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 20, 2024Failure to Eject; Failure to Eject
REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL HAPTIC BECAME STUCK IN THE INJECTOR, AND IT WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THIS REPORT REFLECTS LENS 3 OF 3. REFERENCE REPORT NUMBERS: 0001313525-2024-00119 AND 0001313525-2024-00120.
Patient problems: Insufficient Information
MAUDE report 19787559 ↗InjuryJul 20, 2024Failure to Eject; Failure to Eject
REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL HAPTIC BECAME STUCK IN THE INJECTOR, AND IT WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THIS REPORT REFLECTS LENS 1 OF 3. REFERENCE REPORT NUMBERS: 0001313525-2024-00120 AND 0001313525-2024-00121.
Patient problems: Insufficient Information
MAUDE report 19787558 ↗InjuryJul 20, 2024Failure to Eject; Failure to Eject
REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL HAPTIC BECAME STUCK IN THE INJECTOR, AND IT WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THIS REPORT REFLECTS LENS 2 OF 3. REFERENCE REPORT NUMBERS: 0001313525-2024-00119 AND 0001313525-2024-00121.
Patient problems: Insufficient Information
MAUDE report 19787557 ↗
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- 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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